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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01344655
First received: November 29, 2010
Last updated: July 29, 2013
Last verified: July 2013

November 29, 2010
July 29, 2013
April 2011
September 2012   (final data collection date for primary outcome measure)
Respiratory Impedance by Impulse oscillometry [ Time Frame: from 5 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01344655 on ClinicalTrials.gov Archive Site
  • Exhaled Nitric Oxide [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
  • Multiple Breath Nitrogen Washout [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume in the 1st second [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients

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

A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Atimos®
    Formoterol 12 μg pMDI
    Other Name: Atimos®
  • Drug: Serevent™
    Salmeterol 25 µg pMDI
    Other Name: Serevent™
  • Drug: Placebo
    placebo
  • Experimental: Formoterol 12 μg pMDI (Atimos®)
    Intervention: Drug: Atimos®
  • Active Comparator: Salmeterol 25 µg pMDI HFA (Serevent™)
    Intervention: Drug: Serevent™
  • Placebo Comparator: Matched Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01344655
CCD-0901-PR-0012
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Omar S Usmani, MD Imperial College London
Chiesi Farmaceutici S.p.A.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP