Official Title: “A 24 Week, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsues Administered by HandiHaler Once-Daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Diseas Subjects Naive to Meanitenance Therapy”

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Study Type: Interventional

Study Design: Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: tiotropium inhalation capsules
  • 18mcg/daily

Primary Measures

• The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study).
  • Time Frame: 24 weeks
    

Secondary Measures

• FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor Physician's and patient global assessments Work productivity Use of rescue medication prn albuterol (salbutamol)
  • Time Frame: 24 weeks
    

Inclusion Criteria:

• All subjects must have a diagnosis of COPD according to GOLD guideline criteria:
• post-bronchodilator FEV1/FVC ratio < 70% (visit 1).
• Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and
• < 80% of predicted normal (visit 1).
• Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
• Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion Criteria:

• Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
• Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
• Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3
• Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00523991

Study ID Number: 205.365

ClinicalTrials.gov Identifier: NCT00523991

Health Authority: United States: Institutional Review Board