Official Title: “A Randomised, Open-Label, 4-Way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of Tiotropium and Salmeterol After Inhalation of Tiotropium qd + Salmeterol qd or Bid, Tiotropium qd and Salmeterol Bid”

The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).

Study Type: Interventional

Study Design: Treatment, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Tiotropium+Salmeterol
• Drug: Salmeterol
• Drug: Tiotropium

Primary Measures

• Pharmacokinetics of tiotropium and salmeterol.
  • Time Frame: 16 weeks
    

Secondary Measures

• 1) Pharmacokinetics 2) Safety and tolerability 3) Efficacy
  • Time Frame: 16 weeks
    

Inclusion Criteria:

• COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years

Exclusion Criteria:

• 1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
• 2. History of asthma
• 3. Malignancy requiring treatment within past 5 years
• 4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
• 5. Known active tuberculosis
• 6. Pregnant or nusing women
• 7. Known hypersensitivity to components of the study medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673478

Study ID Number: 1184.24

ClinicalTrials.gov Identifier: NCT00673478

Health Authority: Belgium: Federal Agency for Medicines and Health Products