Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00776984
First received: October 13, 2008
Last updated: May 7, 2014
Last verified: September 2013
  Purpose

The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.


Condition Intervention Phase
Asthma
Drug: tiotropium 5mcg/day
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.


Secondary Outcome Measures:
  • Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Trough FVC Response at the End of the 24-week Treatment Period. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.

  • FVC (AUC0-3h) Response at the End of the 24-week Treatment Period. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.

  • Peak FEV1 0-3h Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Trough FEV1 Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • AUC0-3h FEV1 Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.

  • Peak FVC 0-3h Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Trough FVC Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • FVC AUC0-3h Response at the End of the 48-week Treatment Period. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.

  • Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit . [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit. [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit. [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit. [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit. [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Time to First Severe Asthma Exacerbation During the 48-week Treatment. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.

  • Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.

  • Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.

  • Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.

  • Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.

  • Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.

  • Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • AQLQ(S) Total Score at the End of the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • ACQ Score at the End of the 48-week Treatment Period. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit . [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.

  • Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit . [ Time Frame: Baseline and last 7 days before week 24 visit ] [ Designated as safety issue: No ]
    Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.


Enrollment: 453
Study Start Date: October 2008
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium 5mcg/day
patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Drug: tiotropium 5mcg/day
Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Experimental: placebo
patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Drug: placebo
Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
  2. Male or female patients aged at least 18 years but not more than 75 years.
  3. All patients must have at least a 5-year history of asthma at the time of enrolment into the trial and the diagnosis of asthma must have been made before the patient´s age of 40.
  4. All patients must have a diagnosis of severe persistent asthma and must be symptomatic despite treatment with high, stable doses of inhaled corticosteroids and a long-acting beta adrenergic agent
  5. All patients must have a history of one or more asthma exacerbation in the past year.
  6. Patients must have evidence of treated, severe, persistent asthma in postbronchodilator pulmonary function tests.
  7. Patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years
  8. Patients must be able to use the Respimat® inhaler correctly
  9. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the electronic diary/peak flow meter.

Exclusion criteria:

  1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient´s ability to participate in the trial.
  2. Patients with clinically relevant abnormal screening haematology or blood chemistry.
  3. Patients with a recent history (i.e. six months or less) of myocardial infarction, hospitalisation for cardiac failure during the past year, any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, known active tuberculosis, malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (treated basal cell carcinoma allowed), lung diseases other than asthma (e.g. COPD), significant alcohol or drug abuse within the past two years, patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
  4. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
  5. Patients using oral corticosteroid medication at stable doses exceeding 5 mg prednisolone or prednisolone equivalent every day or 10 mg prednisolone or prednisolone equivalent every second day.
  6. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
  7. Pregnant or nursing women or women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
  8. Patients who have taken an investigational drug within four weeks or six half-lives (whichever is greater) prior to Visit 1.
  9. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®), beta-blocker medication, oral beta-adrenergics, other non-approved and according to international guidelines not recommended ´experimental´ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporin) within four weeks prior to the Screening Visit (Visit 1) or during the screening period.
  10. Patients with any asthma exacerbation or respiratory tract infection in the four weeks prior to the trial.
  11. Patients who have previously been randomised in this trial or in the respective twin trial (205.416 versus 205.417) or are currently participating in another trial.
  12. Patients with a known narrow-angle glaucoma.

Note:

As with other anticholinergic drugs, tiotropium should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.

As with all predominantly renally excreted drugs, patients with moderate to severe renal impairment (known creatinine clearance of <= 50 mL/min) treated with tiotropium should be monitored closely.

  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: NCT00776984

  Hide Study Locations
Locations
United States, California
205.417.01061 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
205.417.01052 Boehringer Ingelheim Investigational Site
Fresno, California, United States
205.417.01051 Boehringer Ingelheim Investigational Site
Stockton, California, United States
United States, Connecticut
205.417.01056 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
United States, Florida
205.417.01065 Boehringer Ingelheim Investigational Site
Pensacola, Florida, United States
United States, Illinois
205.417.01059 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
205.417.01068 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Kentucky
205.417.01063 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Louisiana
205.417.01064 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Nebraska
205.417.01066 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New Jersey
205.417.01069 Boehringer Ingelheim Investigational Site
Ocean, New Jersey, United States
United States, New York
205.417.01062 Boehringer Ingelheim Investigational Site
Albany, New York, United States
205.417.01058 Boehringer Ingelheim Investigational Site
Great Neck, New York, United States
205.417.01055 Boehringer Ingelheim Investigational Site
Rockville Centre, New York, United States
United States, North Carolina
205.417.01067 Boehringer Ingelheim Investigational Site
High Point, North Carolina, United States
United States, Ohio
205.417.01070 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
United States, Pennsylvania
205.417.01053 Boehringer Ingelheim Investigational Site
Upland, Pennsylvania, United States
United States, Virginia
205.417.01054 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Australia, New South Wales
205.417.61051 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
Canada, Ontario
205.417.02051 Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
205.417.02053 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Canada, Quebec
205.417.02052 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Denmark
205.417.45052 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
205.417.45051 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
Germany
205.417.49052 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.417.49054 Boehringer Ingelheim Investigational Site
Hamburg, Germany
205.417.49053 Boehringer Ingelheim Investigational Site
Lübeck, Germany
205.417.49051 Boehringer Ingelheim Investigational Site
Rüdersdorf, Germany
205.417.49055 Boehringer Ingelheim Investigational Site
Weinheim, Germany
Italy
205.417.39052 Boehringer Ingelheim Investigational Site
Bussolengo (vr), Italy
205.417.39054 Boehringer Ingelheim Investigational Site
Milano, Italy
205.417.39051 Boehringer Ingelheim Investigational Site
Pavia, Italy
205.417.39053 Boehringer Ingelheim Investigational Site
Pietra Ligure (sv), Italy
Japan
205.417.81063 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
205.417.81056 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima, Japan
205.417.81051 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
205.417.81059 Boehringer Ingelheim Investigational Site
Kagoshima, Kagoshima, Japan
205.417.81053 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka, Japan
205.417.81057 Boehringer Ingelheim Investigational Site
Kitakyusyu, Fukuoka, Japan
205.417.81058 Boehringer Ingelheim Investigational Site
Koga, Fukuoka, Japan
205.417.81055 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
205.417.81064 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
205.417.81062 Boehringer Ingelheim Investigational Site
Morioka, Iwate, Japan
205.417.81052 Boehringer Ingelheim Investigational Site
Osaka-sayama, Osaka, Japan
205.417.81066 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
205.417.81065 Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan
205.417.81061 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
205.417.81060 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
205.417.81054 Boehringer Ingelheim Investigational Site
Wakayama, Wakayama, Japan
Netherlands
205.417.31051 Boehringer Ingelheim Investigational Site
Groningen, Netherlands
205.417.31053 Boehringer Ingelheim Investigational Site
Leeuwarden, Netherlands
205.417.31052 Boehringer Ingelheim Investigational Site
Schiedam, Netherlands
New Zealand
205.417.64054 Boehringer Ingelheim Investigational Site
Auckland NZ, New Zealand
205.417.64053 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
205.417.64052 Boehringer Ingelheim Investigational Site
Newtown Wellington NZ, New Zealand
205.417.64051 Boehringer Ingelheim Investigational Site
Tauranga, New Zealand
Russian Federation
205.417.07053 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.417.07052 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.417.07051 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Serbia
205.417.38153 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
205.417.38151 Boehringer Ingelheim Investigational Site
Nis, Serbia
205.417.38152 Boehringer Ingelheim Investigational Site
Sremska Kamenica, Serbia
South Africa
205.417.27051 Boehringer Ingelheim Investigational Site
Bellville, South Africa
205.417.27054 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
205.417.27053 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
205.417.27052 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
Turkey
205.417.90053 Boehringer Ingelheim Investigational Site
Ankara, Turkey
205.417.90052 Boehringer Ingelheim Investigational Site
Ankara, Turkey
205.417.90051 Boehringer Ingelheim Investigational Site
Izmit, Turkey
Ukraine
205.417.38053 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
205.417.38051 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
205.417.38052 Boehringer Ingelheim Investigational Site
Vinnytsya, Ukraine
United Kingdom
205.417.44051 Boehringer Ingelheim Investigational Site
Chertsey, United Kingdom
205.417.44053 Boehringer Ingelheim Investigational Site
Exeter, United Kingdom
205.417.44052 Boehringer Ingelheim Investigational Site
Windsor, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Pfizer
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
ClinicalTrials.gov Identifier: NCT00776984     History of Changes
Other Study ID Numbers: 205.417, 2008-001414-25
Study First Received: October 13, 2008
Results First Received: July 20, 2012
Last Updated: May 7, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Therapeutic Products Directorate
Denmark: The Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency of Serbia, 11152 Belgrade
South Africa: Medicines Control Council
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Tiotropium
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014