Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients

Study Identifier:
CCD-0901-PR-0012
ClinicalTrials.gov Identifier:
NCT01344655
EudraCT Identifier:
2008-008656-16
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: Atimos®
  • Drug: Serevent™
  • Drug: Placebo
Date
Apr 2011 - Sep 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Patients with a clinical diagnosis of COPD
  • Post bronchodilator FEV1 between 30% and 80% predicted values at screening
  • Post-bronchodilator FEV1/FVC \< 0.7
Exclusion Criteria
  • Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
  • History of another medical condition contraindicating participation in the study
  • Clinical evidence of heart failure
Healthy Volunteers
No

Protocol Summary

This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Study Locations

Location
Status
Location
Airway Disease Section, NHLI, Imperial College London
London, United Kingdom, SW3 6LY
Status
N/A