Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144339
First received: September 2, 2005
Last updated: May 15, 2014
Last verified: April 2014
  Purpose

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

  • Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.


Secondary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

  • Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
    Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

  • Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  • Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  • Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  • Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
    Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  • Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From month 6 to 4 years ]
    SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).

  • Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
    Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  • Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
    Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  • Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
    Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  • Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
    Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  • Time to First Exacerbation [ Time Frame: From Day 1 to 4 years ]
    Chronic obstructive pulmonary disease (COPD) exacerbation

  • Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year [ Time Frame: Day 1 to 4 years ]
  • Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: Day 1 to 4 years ]
  • Number of Exacerbation Days Per Patient Year [ Time Frame: Day 1 to 4 years ]
    Number of exacerbation days normalized by treatment exposure

  • Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) [ Time Frame: Day 1 to 4 years ]
  • Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
  • Number of Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
    Estimated number of exacerbations leading to hospitalizations per patient year

  • Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
    Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)

  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
    Estimated FEV1 before bronchodilator at Month 1

  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
    Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1

  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ]
    Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6

  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ]
    Estimated FEV1 after bronchodilator at Month 42

  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ]
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ]
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ]
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ]
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 [ Time Frame: Month 6 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 [ Time Frame: Month 12 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 [ Time Frame: Month 18 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 [ Time Frame: Month 24 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 [ Time Frame: Month 30 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 [ Time Frame: Month 36 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 [ Time Frame: Month 42 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 [ Time Frame: Month 48 ]
    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  • Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
    On-treatment defined as day 1 to completion of double blinded treatment plus 30 days

  • Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]
    All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.

  • Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
    The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days

  • Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]
    The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used


Other Outcome Measures:
  • Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Angina) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  • Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.


Enrollment: 5993
Study Start Date: December 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Male or female patients 40 years of age or older.
  • Smoking history of at least 10 pack years.
  • Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

  • Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
  • Myocardial infarction in past 6 months.
  • Unstable or life threatening arrhythmia in past year.
  • Hospitalization for NYHA heart failure class III or IV in past year.
  • Active tuberculosis.
  • Asthma.
  • Pulmonary resection.
  • Malignancy treated with radiation or chemotherapy in past 5 years.
  • Respiratory infection in 4 weeks prior to screening.
  • Known hypersensitivity to anticholinergic drugs or components.
  • Known moderate to severe renal impairment.
  • Known narrow angle glaucoma.
  • Significant symptomatic BPH or bladder neck obstruction.
  • Need for oxygen therapy >12 hr/day.
  • Use of oral corticosteroids at unstable doses or >10 mg/day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144339

  Hide Study Locations
Locations
United States, Alabama
205.235.3779 Boehringer Ingelheim Investigational Site
Anniston, Alabama, United States
205.235.3785 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.235.3804 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
205.235.3795 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
United States, Arizona
205.235.3759 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
205.235.3770 Boehringer Ingelheim Investigational Site
Carmichael, California, United States
205.235.3778 Boehringer Ingelheim Investigational Site
Escondito, California, United States
205.235.3810 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
205.235.3758 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
205.235.3812 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
205.235.3802 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
205.235.3800 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
205.235.3773 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
205.235.3786 Pulmonary and Critical Care Medicine
Orange, California, United States
205.235.3811 Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
205.235.3741 Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
205.235.3717 Boehringer Ingelheim Investigational Site
San Diego, California, United States
205.235.3781 Boehringer Ingelheim Investigational Site
San Diego, California, United States
205.235.3784 Boehringer Ingelheim Investigational Site
San Diego, California, United States
205.235.3760 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
205.235.3711 Boehringer Ingelheim Investigational Site
Stockton, California, United States
United States, Colorado
205.235.3764 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
205.235.3783 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Connecticut
205.235.3808 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
205.235.3727 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
205.235.3793 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
205.235.3815 Boehringer Ingelheim Investigational Site
WEst Haven, Connecticut, United States
United States, Florida
205.235.3706 Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
205.235.3762 Boehringer Ingelheim Investigational Site
Brandon, Florida, United States
205.235.3707 Boehringer Ingelheim Investigational Site
Largo, Florida, United States
205.235.3703 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
205.235.3775 Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
205.235.3743 Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
205.235.3756 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
205.235.3739 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
United States, Georgia
205.235.3719 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
205.235.3790 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
205.235.3716 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States
205.235.3794 Boehringer Ingelheim Investigational Site
Stockbridge, Georgia, United States
United States, Idaho
205.235.3724 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
United States, Illinois
205.235.3713 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Indiana
205.235.3768 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Iowa
205.235.3749 Boehringer Ingelheim Investigational Site
Dubuque, Iowa, United States
United States, Kansas
205.235.3757 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
United States, Kentucky
205.235.3729 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
205.235.3737 Boehringer Ingelheim Investigational Site
Metairie, Louisiana, United States
205.235.3788 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Maine
205.235.3750 Boehringer Ingelheim Investigational Site
Bidderford, Maine, United States
United States, Maryland
205.235.3806 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
205.235.3721 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
205.235.3726 354 Birnie Ave
Springfield, Massachusetts, United States
United States, Michigan
205.235.3813 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
205.235.3732 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
205.235.3809 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
United States, Minnesota
205.235.3754 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
205.235.3751 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
205.235.3789 Boehringer Ingelheim Investigational Site
Rochester, Minnesota, United States
United States, Missouri
205.235.3734 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
205.235.3814 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
205.235.3747 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, New Hampshire
205.235.3763 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, New Jersey
205.235.3797 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
205.235.3799 Boehringer Ingelheim Investigational Site
Summit, New Jersey, United States
United States, New York
205.235.3796 Boehringer Ingelheim Investigational Site
Albany, New York, United States
205.235.3807 Boehringer Ingelheim Investigational Site
Bayshore, New York, United States
205.235.3816 Boehringer Ingelheim Investigational Site
Bronx, New York, United States
205.235.3765 Boehringer Ingelheim Investigational Site
Larchmont, New York, United States
205.235.3748 Boehringer Ingelheim Investigational Site
Mineola, New York, United States
205.235.3818 Boehringer Ingelheim Investigational Site
New York, New York, United States
205.235.3722 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
United States, North Carolina
205.235.3730 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
205.235.3731 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
205.235.3736 Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States
205.235.3745 Boehringer Ingelheim Investigational Site
Elizabath City, North Carolina, United States
205.235.3712 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Ohio
205.235.3723 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
205.235.3701 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
United States, Oklahoma
205.235.3791 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
205.235.3820 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
205.235.3725 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania, United States
205.235.3817 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Rhode Island
205.235.3715 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, Texas
205.235.3803 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
205.235.3787 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
205.235.3742 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
205.235.3704 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Utah
205.235.3752 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
205.235.3744 Boehringer Ingelheim Investigational Site
Danville, Virginia, United States
205.235.3782 Boehringer Ingelheim Investigational Site
Fredericksburg, Virginia, United States
205.235.3771 Boehringer Ingelheim Investigational Site
Lynchburg, Virginia, United States
205.235.3738 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
205.235.3792 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
205.235.3761 Boehringer Ingelheim Investigational Site
Salem, Virginia, United States
United States, Washington
205.235.3718 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
United States, Wisconsin
205.235.3780 Boehringer Ingelheim Investigational Site
La Crosse, Wisconsin, United States
Argentina
205.235.101
Buenos Aires, Argentina
205.235.103 Hospital Alemán
Capital Federal, Argentina
205.235.107 Policlínica Bancaria
Capital Federal, Argentina
205.235.101 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
205.235.108 Hospital General de Agudos Dr. Enrique Tornú
Capital Federal, Argentina
205.235.105 Hospital General de Agudos José María Ramos Mejía
Capital Federal, Argentina
205.235.109 Hospital Muñiz
Capital Federal, Argentina
205.235.104 Hospital de Clinicas José de San Martín
Capital Federal, Argentina
205.235.110 Hospital Privado - Centro Médico de Córdoba S.A.
Parque Velez Sarlfield, Argentina
205.235.102 Instituto Cardiovascular de Rosario
Rosario, Argentina
205.235.106 Hospital Cetrángolo
Vicente López, Argentina
Australia, New South Wales
205.235.0205 Boehringer Ingelheim Investigational Site
Bankstown, New South Wales, Australia
205.235.0202 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
205.235.0209 Boehringer Ingelheim Investigational Site
Westmead, New South Wales, Australia
Australia, Queensland
205.235.0204 Boehringer Ingelheim Investigational Site
Cairns, Queensland, Australia
205.235.0203 Boehringer Ingelheim Investigational Site
Redcliffe, Queensland, Australia
Australia, South Australia
205.235.0207 Boehringer Ingelheim Investigational Site
Port Lincoln, South Australia, Australia
Australia, Victoria
205.235.0206 Boehringer Ingelheim Investigational Site
Box Hill, Victoria, Australia
205.235.0201 Boehringer Ingelheim Investigational Site
Geelong, Victoria, Australia
Austria
205.235.0303 Boehringer Ingelheim Investigational Site
Graz, Austria
205.235.0305 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
205.235.0304 Boehringer Ingelheim Investigational Site
Leoben, Austria
205.235.0302 Boehringer Ingelheim Investigational Site
Wien, Austria
205.235.0301 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
205.235.0439 Boehringer Ingelheim Investigational Site
Anderlecht, Belgium
205.235.0429 Boehringer Ingelheim Investigational Site
Baudour, Belgium
205.235.0421 Boehringer Ingelheim Investigational Site
Brugge, Belgium
205.235.0424 Boehringer Ingelheim Investigational Site
Brussel, Belgium
205.235.0432 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
205.235.0434 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
205.235.0422 Boehringer Ingelheim Investigational Site
Dendermonde, Belgium
205.235.0405 Boehringer Ingelheim Investigational Site
Edegem, Belgium
205.235.0414 Boehringer Ingelheim Investigational Site
Gent, Belgium
205.235.0418 U.Z. Gent
Gent, Belgium
205.235.0417 Boehringer Ingelheim Investigational Site
Herentals, Belgium
205.235.0402 Boehringer Ingelheim Investigational Site
Ieper, Belgium
205.235.0409 Boehringer Ingelheim Investigational Site
Kortrijk, Belgium
205.235.0407 Boehringer Ingelheim Investigational Site
Leuven, Belgium
205.235.0440 Boehringer Ingelheim Investigational Site
Luxembourg, Belgium
205.235.0403 Boehringer Ingelheim Investigational Site
Menen, Belgium
205.235.0406 Boehringer Ingelheim Investigational Site
Merksem, Belgium
205.235.0404 Boehringer Ingelheim Investigational Site
Middelheim, Belgium
205.235.0438 Boehringer Ingelheim Investigational Site
Mons, Belgium
205.235.0437 Boehringer Ingelheim Investigational Site
Namur, Belgium
205.235.0420 Boehringer Ingelheim Investigational Site
Neerpelt, Belgium
205.235.0435 Boehringer Ingelheim Investigational Site
Nobressart (ATTERT), Belgium
205.235.0423 Boehringer Ingelheim Investigational Site
Oostende, Belgium
205.235.0433 Boehringer Ingelheim Investigational Site
Tournai, Belgium
205.235.0412 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
205.235.0413 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
205.235.0428 Boehringer Ingelheim Investigational Site
Yvoir, Belgium
Brazil
205.235.510 Servico de Pneumologia
Florianópolis - SC, Brazil
205.235.508
Juiz de Fora - MG, Brazil
205.235.507 Depto.de Medicina Interna-Servico de pneumologia
Porto Alegre - RS, Brazil
205.235.501
Porto Alegre - RS, Brazil
205.235.503
Porto Alegre - RS, Brazil
205.235.506
Porto Alegre - RS, Brazil
205.235.502
Rio de Janeiro - RJ, Brazil
205.235.505 Dep.Medicina Especializada (DEMESP)
Rio de Janeiro - RJ, Brazil
205.235.511 Departamento de Pneumologia
Salvador - BA, Brazil
205.235.504 ANEXO 2-Laboratório de Funcao Pulmonar
Santo André - SP, Brazil
205.235.515 Lar Escola São Francisco / Setor de Pneumologia
São Paulo - SP, Brazil
205.235.513
São Paulo - SP, Brazil
205.235.514 Unidade de Coracao e Pulmao do Dto. de Medicina
São Paulo - SP, Brazil
205.235.512
São Paulo - SP, Brazil
Czech Republic
205.235.0712 Boehringer Ingelheim Investigational Site
Benesov, Czech Republic
205.235.0711 Boehringer Ingelheim Investigational Site
Beroun, Czech Republic
205.235.0725 University Hospital Brno
Brno, Czech Republic
205.235.0718 Clinic of Functional Diagnostics and Rehabilitation
Brno, Czech Republic
205.235.0720 Office of Pulmonology and Respiratory Diseases
Cesky Tesin, Czech Republic
205.235.0717 Pulmonary Clinic
Hradec Kralove, Czech Republic
205.235.0705 Boehringer Ingelheim Investigational Site
Jablonec nad Nisou, Czech Republic
205.235.0726 Private Office of Pulmonary Diseases
Jaromer, Czech Republic
205.235.0722 Hospital Kromeriz
Kromeriz, Czech Republic
205.235.0724 District Hospital Kyjov
Kyjov, Czech Republic
205.235.0704 Boehringer Ingelheim Investigational Site
Lovosice, Czech Republic
205.235.0702 Boehringer Ingelheim Investigational Site
Marianske Lazne, Czech Republic
205.235.0701 Boehringer Ingelheim Investigational Site
Plzen, Czech Republic
205.235.0703 Boehringer Ingelheim Investigational Site
Plzen, Czech Republic
205.235.0710 Boehringer Ingelheim Investigational Site
Prague 5, Czech Republic
205.235.0709 Boehringer Ingelheim Investigational Site
Praha 4, Czech Republic
205.235.0706 Boehringer Ingelheim Investigational Site
Praha 4, Czech Republic
205.235.0715 Boehringer Ingelheim Investigational Site
Praha 5, Czech Republic
205.235.0708 Boehringer Ingelheim Investigational Site
Praha 5 - Nove Butovice, Czech Republic
205.235.0707 Boehringer Ingelheim Investigational Site
Praha 8, Czech Republic
205.235.0723 Office of Pulmonary and Respiratory Diseases
Prerov, Czech Republic
205.235.0721 Office of Pulmonary Diseases
Pribor, Czech Republic
205.235.0713 Boehringer Ingelheim Investigational Site
Strakonice, Czech Republic
205.235.0714 Boehringer Ingelheim Investigational Site
Tabor, Czech Republic
205.235.0719 Office of Pulmonology and Respiratory Diseases
Usti nad Orlici, Czech Republic
205.235.0716 Boehringer Ingelheim Investigational Site
Znojmo, Czech Republic
Denmark
205.235.0804 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
205.235.0826 Boehringer Ingelheim Investigational Site
Aalborg SV, Denmark
205.235.0803 Boehringer Ingelheim Investigational Site
Aarhus, Denmark
205.235.0831 Boehringer Ingelheim Investigational Site
Copenhagen, Denmark
205.235.0828 Boehringer Ingelheim Investigational Site
Copenhagen K, Denmark
205.235.0802 Boehringer Ingelheim Investigational Site
Copenhagen NV, Denmark
205.235.0821 Boehringer Ingelheim Investigational Site
Frederikshavn, Denmark
205.235.0832 Boehringer Ingelheim Investigational Site
Frederikssund, Denmark
205.235.0807 Boehringer Ingelheim Investigational Site
Fåborg, Denmark
205.235.0835 Boehringer Ingelheim Investigational Site
Hellerup, Denmark
205.235.0805 Boehringer Ingelheim Investigational Site
Hellerup, Denmark
205.235.0816 Boehringer Ingelheim Investigational Site
Helsingor, Denmark
205.235.0811 Boehringer Ingelheim Investigational Site
Hillerød, Denmark
205.235.0834 Boehringer Ingelheim Investigational Site
Hobro, Denmark
205.235.0806 Boehringer Ingelheim Investigational Site
Holbæk, Denmark
205.235.0814 Boehringer Ingelheim Investigational Site
Holstebro, Denmark
205.235.0801 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
205.235.0833 Boehringer Ingelheim Investigational Site
Kalundborg, Denmark
205.235.0830 Boehringer Ingelheim Investigational Site
Kolding, Denmark
205.235.0819 Boehringer Ingelheim Investigational Site
Nykobing F., Denmark
205.235.0810 Boehringer Ingelheim Investigational Site
Næstved, Denmark
205.235.0809 Boehringer Ingelheim Investigational Site
Odense C, Denmark
205.235.0815 Boehringer Ingelheim Investigational Site
Randers, Denmark
205.235.0824 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
205.235.0813 Boehringer Ingelheim Investigational Site
Skive, Denmark
205.235.0822 Boehringer Ingelheim Investigational Site
Skive, Denmark
205.235.0820 Boehringer Ingelheim Investigational Site
Slagelse, Denmark
205.235.0808 Boehringer Ingelheim Investigational Site
Svendborg, Denmark
205.235.0827 Boehringer Ingelheim Investigational Site
Værløse, Denmark
Finland
205.235.0903 Boehringer Ingelheim Investigational Site
Helsinki, Finland
205.235.0901 Boehringer Ingelheim Investigational Site
Jyväskylä, Finland
205.235.0905 Boehringer Ingelheim Investigational Site
Kotka, Finland
205.235.0904 Boehringer Ingelheim Investigational Site
Lahti, Finland
205.235.0902 Boehringer Ingelheim Investigational Site
Pori, Finland
France
205.235.1007 Cabinet Médical
Albi, France
205.235.1004 Clinique Toulouse Lautrec
Albi cedex 9, France
205.235.1015 Centre Hospitalier
Barbezieux St Hilaire, France
205.235.1012 Cabinet Médical
Bourges, France
205.235.1024 Cabinet Médical
Chamalières, France
205.235.1006 Centre Hospitalier de Chauny
Chauny cedex, France
205.235.1005 Polyclinique
Cholet, France
205.235.1013 Cabinet Médical
La Teste, France
205.235.1020 Cabinet Médical
Marseille, France
205.235.1023 Cabinet Médical
Montauban, France
205.235.1025 Centre Médical Erdre Saint Augustin
Nantes, France
205.235.1002 Cabinet médical
Nice, France
205.235.1001 Hôpital Bichat
Paris, France
205.235.1016 Cabinet Médical
Provins, France
205.235.1019 Cabinet Médical
Strasbourg, France
205.235.1009 Centre Hospitalier de Bigorre
Tarbes cedex 9, France
205.235.1021 Clinique Pasteur
Toulouse, France
Germany
205.235.1113 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.235.1114 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.235.1103 Boehringer Ingelheim Investigational Site
Brake, Germany
205.235.1105 Boehringer Ingelheim Investigational Site
Braunschweig, Germany
205.235.1104 Boehringer Ingelheim Investigational Site
Bruchsal, Germany
205.235.1115 Boehringer Ingelheim Investigational Site
Hannover, Germany
205.235.1109 Boehringer Ingelheim Investigational Site
Kaufbeuren, Germany
205.235.1108 Boehringer Ingelheim Investigational Site
Lörrach, Germany
205.235.1102 Boehringer Ingelheim Investigational Site
Lübeck, Germany
205.235.1110 Boehringer Ingelheim Investigational Site
München, Germany
205.235.1106 Boehringer Ingelheim Investigational Site
München, Germany
205.235.1101 Boehringer Ingelheim Investigational Site
Ulm, Germany
205.235.1107 Boehringer Ingelheim Investigational Site
Weyhe, Germany
205.235.1112 Boehringer Ingelheim Investigational Site
Wiesloch, Germany
Greece
205.235.1203 Boehringer Ingelheim Investigational Site
Athens, Greece
205.235.1202 8th Pulmonology Clinic "Sotiria" Athens Chest Hospital
Athens, Greece
205.235.1201 Boehringer Ingelheim Investigational Site
Heraklion, Greece
205.235.1211 Boehringer Ingelheim Investigational Site
Kavala, Greece
205.235.1204 Boehringer Ingelheim Investigational Site
Larissa, Greece
205.235.1210 Boehringer Ingelheim Investigational Site
Patra, Greece
205.235.1209 Boehringer Ingelheim Investigational Site
Patra, Greece
205.235.1207 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
205.235.1206 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
205.235.1205 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Hong Kong
205.235.1401 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
205.235.1403 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
205.235.1404 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
205.235.1402 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
Hungary
205.235.1308 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.235.1303 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.235.1310 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.235.1309 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.235.1311 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.235.1318 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
205.235.1314 Boehringer Ingelheim Investigational Site
Deszk, Hungary
205.235.1306 Boehringer Ingelheim Investigational Site
Erd, Hungary
205.235.1315 Boehringer Ingelheim Investigational Site
Farkasgyepü, Hungary
205.235.1320 Boehringer Ingelheim Investigational Site
Gyula, Hungary
205.235.1307 Boehringer Ingelheim Investigational Site
Kiskunhalas, Hungary
205.235.1304 Boehringer Ingelheim Investigational Site
Miskolc, Hungary
205.235.1317 Boehringer Ingelheim Investigational Site
Mosonmagyarovar, Hungary
205.235.1301 Boehringer Ingelheim Investigational Site
Pecs, Hungary
205.235.1313 Boehringer Ingelheim Investigational Site
Solymar, Hungary
205.235.1305 Boehringer Ingelheim Investigational Site
Sopron, Hungary
205.235.1319 Boehringer Ingelheim Investigational Site
Szombathely, Hungary
205.235.1302 Boehringer Ingelheim Investigational Site
Tatabanya, Hungary
205.235.1316 Boehringer Ingelheim Investigational Site
Törökbalint, Hungary
205.235.1312 Boehringer Ingelheim Investigational Site
Veszprem, Hungary
Ireland
205.235.1505 Boehringer Ingelheim Investigational Site
Dublin 15, Ireland
205.235.1503 Boehringer Ingelheim Investigational Site
Dublin 4, Ireland
205.235.1501 Boehringer Ingelheim Investigational Site
Dublin 9, Ireland
Italy
205.235.1631 A. O. SS. Antonio e Biagio e Arrigo
Alessandria, Italy
205.235.1613 A. O. S. Giuseppe Moscati
Avellino, Italy
205.235.1618 Ospedale Bellaria
Bologna, Italy
205.235.1649 Ospedale di Circolo di Busto Arsizio
Busto Arsizio (VA), Italy
205.235.1635 P. O. Roberto Binaghi
Cagliari, Italy
205.235.1623 A. O. di Carrara
Carrara (Massa), Italy
205.235.1645 Ospedale Civile "Zappatoni"
CASSANO D'ADDA (Milano), Italy
205.235.1617 Ospedale S. Camillo De Lellis
Chieti, Italy
205.235.1612 A. O. S. Antonio Abate
Erice (Trapani), Italy
205.235.1622 A. O. S. Anna
Ferrara, Italy
205.235.1647 A. O. Careggi
Firenze, Italy
205.235.1646 A. O. di Careggi
Firenze, Italy
205.235.1615 Ospedale S. Martino
Genova, Italy
205.235.1603 P. O. di Gubbio
Gubbio (Perugia), Italy
205.235.1619 A. O. Fratelli Crobu
Iglesias (Cagliari), Italy
205.235.1648 Ospedale "S. Maria di Collemaggio"
L'Aquila, Italy
205.235.1624 Ospedale di Macerata
Macerata, Italy
205.235.1634 P. O. Luigi Sacco
Milano, Italy
205.235.1639 Ospedale Maggiore
Modica (Ragusa), Italy
205.235.1629 A. O. S. Luigi Gonzaga
Orbassano (Torino), Italy
205.235.1604 P. O. R. Silvestrini
Perugia, Italy
205.235.1601 Presidio Ospedaliero di Cisanello
Pisa, Italy
205.235.1643 A. O. Santa Maria degli Angeli
Pordenone, Italy
205.235.1614 Ospedale Misericordia e Dolce
Prato, Italy
205.235.1608 ASL 1 di Sassari
Sassari, Italy
205.235.1607 Università degli Studi di Sassari
Sassari, Italy
205.235.1606 ASL 4 di Terni
Terni, Italy
205.235.1632 ASL 4 - Distretto 2
Torino, Italy
205.235.1633 A. O. Umberto I
Torrette di Ancona (Ancona), Italy
205.235.1640 P. O. Cà Foncello
Treviso, Italy
205.235.1602 Ospedale di Voghera
Voghera (Pavia), Italy
Japan
205.235.1706 Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
205.235.1705 Kameda Medical Center
Kamogawa, Chiba, Japan
205.235.1713 Komaki City Hospital
Komaki, Aichi, Japan
205.235.1712 Kurume University Hospital
Kurume, Fukuoka, Japan
205.235.1708 Shinshu University
Matsumoto, Nagano, Japan
205.235.1702 Iwate Medical University Hospital
Morioka, Iwate, Japan
205.235.1710 Osaka City University Hospital
Osaka, Osaka, Japan
205.235.1711 Kinki University Hospital
Osakasayama, Osaka, Japan
205.235.1701 Hokkaido University
Sapporo, Hokkaido, Japan
205.235.1703 Tohoku University Hospital
Sendai, Miyagi, Japan
205.235.1709 Tosei General Hospital
Seto, Aichi, Japan
205.235.1704 Hiraka General Hospital
Yokote, Akita, Japan
Lithuania
205.235.1801 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.235.1802 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.235.1803 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
Malaysia
205.235.1903 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
205.235.1902 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
205.235.1901 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
Mexico
205.235.2005
Ciudad de Mexico, Mexico
205.235.2006 Tlalpan 4000, Pabellón 5, EPOC
Ciudad de Mexico, Mexico
205.235.2004 Edif. Dr. Rodrigo F. Barragan, P.B.
Col. Mitras Centro, Monterrey, N.L., Mexico
205.235.2002
Guadalajara, Jal., Mexico
205.235.2009
Puebla, Mexico
205.235.2010 Depto. De Ivestigación
Toluca, Mexico
205.235.2003
Zapopan, jalisco, Mexico
Netherlands
205.235.2110 Poli Longziekten
Almelo, Netherlands
205.235.2105 Lokatie De Lichtenberg
Amersfoort, Netherlands
205.235.2107 Poli Longziekten
Delft, Netherlands
205.235.2106 Lokatie Dordwijk
Dordrecht, Netherlands
205.235.2104 Poli longziekten
Eindhoven, Netherlands
205.235.2102 Martini Ziekenhuis Groningen
Groningen, Netherlands
205.235.2112 Poli Longziekten
Harderwijk, Netherlands
205.235.2115 Poli Longziekten
Heerenveen, Netherlands
205.235.2101 Atrium medisch centrum
Heerlen, Netherlands
205.235.2114 Poli Longziekten
Hengelo, Netherlands
205.235.2108 Poli Longziekten
Leeuwarden, Netherlands
205.235.2109 Poli Longziekten
Rotterdam, Netherlands
205.235.2111 Antonius Ziekenhuis
Sneek, Netherlands
New Zealand
205.235.0211 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
205.235.0212 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand, New Zealand
Norway
205.235.2202 Boehringer Ingelheim Investigational Site
Arendal, Norway
205.235.2201 Boehringer Ingelheim Investigational Site
Fredrikstad, Norway
205.235.2205 Boehringer Ingelheim Investigational Site
Sandvika, Norway
205.235.2204 Boehringer Ingelheim Investigational Site
Straume, Norway
Philippines
205.235.2305 University of Santo Tomas Hospital
Manila, Philippines
205.235.2301 Philippine General Hospital
Manila, Philippines
205.235.2302 Philippine Heart Center
Quezon City, Philippines
205.235.2303 Veterans Memorial Medical Center
Quezon City, Philippines
205.235.2304 Lung Center of the Philippines
Quezon City, Philippines
Poland
205.235.2410 Boehringer Ingelheim Investigational Site
Gdansk, Poland
205.235.2407 Boehringer Ingelheim Investigational Site
Katowice, Poland
205.235.2408 Boehringer Ingelheim Investigational Site
Krakow, Poland
205.235.2409 Boehringer Ingelheim Investigational Site
Lodz, Poland
205.235.2405 Boehringer Ingelheim Investigational Site
Lodz, Poland
205.235.2402 Boehringer Ingelheim Investigational Site
Warsaw, Poland
205.235.2403 Boehringer Ingelheim Investigational Site
Warsaw, Poland
205.235.2401 Boehringer Ingelheim Investigational Site
Warsaw, Poland
205.235.2404 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
205.235.2406 Boehringer Ingelheim Investigational Site
Zabrze, Poland
Portugal
205.235.2504 Centro Hospitalar de Coimbra
Coimbra, Portugal
205.235.2503 Hospital Pulido Valente
Lisboa, Portugal
205.235.2505 Hospital de Santa Marta
Lisboa, Portugal
205.235.2501 Hospital de São João
Porto, Portugal
205.235.2502 Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Russian Federation
205.235.2602 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.235.2603 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.235.2605 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.235.2601 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.235.2604 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Singapore
205.235.1906 Boehringer Ingelheim Investigational Site
Singapore, Singapore
205.235.1905 Boehringer Ingelheim Investigational Site
Singapore, Singapore
205.235.1904 Boehringer Ingelheim Investigational Site
Singapore, Singapore
Slovakia
205.235.2701 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
205.235.2702 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
205.235.2703 Boehringer Ingelheim Investigational Site
Martin, Slovakia
205.235.2704 Boehringer Ingelheim Investigational Site
Poprad, Slovakia
205.235.2705 Boehringer Ingelheim Investigational Site
Topolcany, Slovakia
Slovenia
205.235.2801 Boehringer Ingelheim Investigational Site
Golnik, Slovenia
205.235.2802 Boehringer Ingelheim Investigational Site
Golnik, Slovenia
205.235.2805 Boehringer Ingelheim Investigational Site
Kamnik, Slovenia
205.235.2803 Boehringer Ingelheim Investigational Site
Ljubljana, Slovenia
205.235.2804 Boehringer Ingelheim Investigational Site
Topolsica, Slovenia
South Africa
205.235.2908
Bloemfontein, South Africa
205.235.2910
Cape Town, South Africa
205.235.2912
Cape Town, South Africa
205.235.2904
Durban, South Africa
205.235.2911
Durban, South Africa
205.235.2902
George, South Africa
205.235.2905
Paarl, South Africa
205.235.2901 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
205.235.2906
Somerset West, South Africa
205.235.2903
Vanderbijlpark, South Africa
205.235.2909
Welkom, South Africa
Spain
205.235.3014 Complejo Hospitalario Juan Canalejo
A Coruña, Spain
205.235.3026 Hospital General Universitario de Alicante
Alicante, Spain
205.235.3011 Complejo Hospitalario Infanta Cristina
Badajoz, Spain
205.235.3006 Hospital Germans Trias i Pujol
Badalona (Barcelona), Spain
205.235.3022 Hospital de Cruces
Barakaldo (Bilbao), Spain
205.235.3003 Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
205.235.3008 Hospital Vall d'Hebrón
Barcelona, Spain
205.235.3023 Hospital Dr. Josep Trueta
Girona, Spain
205.235.3004 Hospital General Universitario de Guadalajara
Guadalajara, Spain
205.235.3005 Hospital General San Jorge de Huesca
Huesca, Spain
205.235.3021 Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
205.235.3010 Hospital Severo Ochoa
Leganés, Madrid, Spain
205.235.3036 Hospital 12 de Octubre
Madrid, Spain
205.235.3013 Clínica Puerta de Hierro
Madrid, Spain
205.235.3020 Hospital Universitario La Paz
Madrid, Spain
205.235.3009 Hospital Clínico San Carlos
Madrid, Spain
205.235.3028 Hospital Universitario de la Princesa
Madrid, Spain
205.235.3031 Hospital Gregorio Marañón
Madrid, Spain
205.235.3017 Hospital Ramón y Cajal
Madrid, Spain
205.235.3033 Hospital General Carlos Haya
Málaga, Spain
205.235.3027 Complejo Asistencial Son Dureta
Palma de Mallorca, Spain
205.235.3024 Hospital de Montecelo
Pontevedra, Spain
205.235.3016 Hospital Universitari de Sant Joan
Reus (Tarragona), Spain
205.235.3015 Corporació Sanitaria Parc Taulí de Sabadell
Sabadell (Barcelona), Spain
205.235.3037 Hsopital Universitario Ntra. Sra. de la Candelaria
Santa Cruz de Tenerife, Spain
205.235.3039 Hospital Universitario Marqués de Valdecilla
Santander, Spain
205.235.3019 Hospital Vírgen de la Macarena
Sevilla, Spain
205.235.3035 Hospital Universitario Vírgen del Rocío
Sevilla, Spain
205.235.3001 Hospital Mutua Terrassa
Terrassa (Barcelona), Spain
205.235.3032 Hospital Arnau de Vilanova
Valencia, Spain
205.235.3002 Hospital Clínico Universitario de Valencia
Valencia, Spain
205.235.3025 Hospital Universitario Dr. Peset
Valencia, Spain
205.235.3034 Hospital La Fe
Valencia, Spain
205.235.3018 Complejo Hospitalario Xeral - Cíes
Vigo, Spain
205.235.3030 Hospital Miguel Servet
Zaragoza, Spain
205.235.3038 Hospital Clínico Lozano Blesa
Zaragoza, Spain
Switzerland
205.235.3202 Boehringer Ingelheim Investigational Site
Basel, Switzerland
205.235.3203 Universitätsspital Basel
Basel, Switzerland
205.235.3204 Boehringer Ingelheim Investigational Site
Faltigberg, Switzerland
205.235.3205 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
205.235.3206 Boehringer Ingelheim Investigational Site
Montana, Switzerland
205.235.3208 Boehringer Ingelheim Investigational Site
Winterthur, Switzerland
205.235.3201 Boehringer Ingelheim Investigational Site
Zürich, Switzerland
Taiwan
205.235.3301 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
205.235.3302 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
205.235.3303 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Thailand
205.235.3402 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
205.235.3403 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
205.235.3404 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
205.235.3401 Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
205.235.3405 Boehringer Ingelheim Investigational Site
Khon Kaen, Thailand
Turkey
205.235.3510 Cukurova Tip Fakultesi Balcali Hastanesi
Adana, Turkey
205.235.3507 Ankara SSK Diskapi Egitim Hastanesi
Ankara, Turkey
205.235.3508 Atatürk Gögüs Hastaliklari ve Gögüs Cerrahi
Ankara, Turkey
205.235.3506 Hacettepe Tip Fakultesi
Ankara, Turkey
205.235.3509 Atatürk Üniversitesi Tip Fakultesi Aziziye
Erzurum, Turkey
205.235.3511 Osmangazi Universitesi Tip Fakültesi
Eskisehir, Turkey
205.235.3501 Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey
205.235.3502 Yedikule Gögüs Hastaliklari Hastanesi
Istanbul, Turkey
205.235.3503 Tophanelioglu Cad. No: 13/15
Istanbul, Turkey
205.235.3504 Cevizli E5 Karayolu
Istanbul, Turkey
205.235.3505 Istanbul Universitesi Tip Fakültesi
Istanbul, Turkey
205.235.3512 DokuzEylül Universitesi Tip Fakultesi Gögüs Hastaliklari ABD
Izmir, Turkey
United Kingdom
205.235.3615 Boehringer Ingelheim Investigational Site
Aberdeen, United Kingdom
205.235.3611 Boehringer Ingelheim Investigational Site
Chertsey, United Kingdom
205.235.3613 Boehringer Ingelheim Investigational Site
Chesterfield, United Kingdom
205.235.3608 Boehringer Ingelheim Investigational Site
Cottingham, Hull, United Kingdom
205.235.3605 Boehringer Ingelheim Investigational Site
Exeter, United Kingdom
205.235.3602 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
205.235.3610 Boehringer Ingelheim Investigational Site
Leeds, United Kingdom
205.235.3607 Boehringer Ingelheim Investigational Site
Leicester, United Kingdom
205.235.3604 Boehringer Ingelheim Investigational Site
Middleton, United Kingdom
205.235.3612 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
205.235.3616 Boehringer Ingelheim Investigational Site
Paisley, United Kingdom
205.235.3614 Boehringer Ingelheim Investigational Site
Penarth, United Kingdom
205.235.3603 Boehringer Ingelheim Investigational Site
Plymouth, United Kingdom
205.235.3609 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
205.235.3601 Boehringer Ingelheim Investigational Site
Solihull, Birmingham, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144339     History of Changes
Other Study ID Numbers: 205.235
Study First Received: September 2, 2005
Results First Received: February 21, 2009
Last Updated: May 15, 2014
Health Authority: Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Hungary: National Institute of Pharmacy, H-1051 Budapest
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Slovenia: Agency for Medicinal Products, SI-1000 Ljubljana
Australia: Responsilble Ethics Committee
New Zealand: Multicentre Ethics Committee/Medsafe
Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration
France: AFFSAPS
Hong Kong: Dept. of Health of Hong Kong
Italy: Comitato Etico Az. Osp. Univ. Pisana di Pisa
Malaysia: Ministry of Health, Malaysia
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología)
Taiwan: Department of Health, Executive Yuan, Taiwan
Philippines: Department of Health, Republic of the Philippines
Thailand: Ministry of Public Health
Finland: Finnish Medicines Agency
Singapore: Health Science Authority, Ministry of Health
Switzerland: Swissmedic
Turkey: Ministry of Health Central Ethics Committee
Great Britain: MHRA
South Africa: Medicines Control Council

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014