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: May 2009

Intervention(s) in this Clinical Trial

• Drug: Tiotropium+Salmeterol
  • tiotropium and salmeterol
• Drug: Salmeterol
  • 50 mcg/twice daily
• Drug: Tiotropium
  • 18 mcg/daily

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 nursing 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  

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

Information obtained from ClinicalTrials.gov on October 10, 2008

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

Study ID Number: 1184.24

ClinicalTrials.gov Identifier: NCT00673478

Health Authority: Netherlands: Central Committee on Research Involving Human Subjects (CCMO)