Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

Verified by: Boehringer Ingelheim Pharmaceuticals, May 2009
First Received: September 25, 2007 | Last Updated: May 28, 2009 | Phase: Phase 2 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 103
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This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters...

Brief Summary

Official Title: “A Randomised, Phase II, Double-Blind, Double-Dummy, Four-Period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 Mcg Bid, MDI), Ciclesonide (400 Mcg qd, MDI), Ciclesonide (800 Mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 Mcg qd, HandiHaler) and Salmeterol (50 Mcg Bid, Diskus) in Patients With COPD.”

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

  • Drug: Tiotropium
  • Drug: salmeterol
  • Drug: steroid

Outcome Measures for this Clinical Trial

Primary Measures

  • Trough FEV1 response at the end of each 4 week period of randomised treatment
    • Time Frame: 4 weeks

Secondary Measures

  • Other lung function parameters such as FVC, IC, VC, PEF, DLCO, FENO Occasions of rescue therapy Mahler Dyspnea Indices Safety
    • Time Frame: 4 weeks

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Relatively stable, moderate to severe COPD
  • Male or female patients 40 years of age or older.
  • Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria:

  • Other significant disease that can influence the study results or be a safety risk for the patient
  • Other medication that can influence the study results
  • Hypersensitivity to the study medication
  • Patients with unstable COPD

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

Clinical Trial Investigator Information

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535366

Study ID Number: 1249.1

ClinicalTrials.gov Identifier: NCT00535366

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00535366