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Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
This study has been completed.
First Received: September 2, 2005   Last Updated: August 17, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144339
  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 III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Tiotropium bromide Tiotropium
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 ]
  • 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 ]

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. ]
  • 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 ]
  • Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  • Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  • Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  • 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 St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From month 6 to 4 years ]
  • 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. ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Time to First Exacerbation [ Time Frame: From Day 1 to 4 years ]
  • 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 and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: Day 1 to 4 years ]
  • Number and Percentage of Patients With Time to First 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 ]
  • Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: 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 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 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 [ Time Frame: Month 12 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 [ Time Frame: Month 18 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 [ Time Frame: Month 24 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 [ Time Frame: Month 30 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 [ Time Frame: Month 36 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 [ Time Frame: Month 42 ]
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 [ Time Frame: Month 48 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

  Show 490 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1171-8. Epub 2009 Aug 27.
Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. Epub 2008 Oct 5.

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.235
Study First Received: September 2, 2005
Results First Received: February 21, 2009
Last Updated: August 17, 2009
ClinicalTrials.gov Identifier: NCT00144339     History of Changes
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;   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:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
 Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 04, 2010



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