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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344655
First Posted: April 29, 2011
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
November 29, 2010
April 29, 2011
March 30, 2017
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 ]
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 ]
  • Multiple Breath Nitrogen Washout [ Time Frame: from 30 minutes to 8 hours post dose ]
  • Forced Expiratory Volume in the 1st second [ Time Frame: from 30 minutes to 8 hours post dose ]
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Atimos®
    Formoterol 12 μg pMDI
  • Drug: Serevent™
    Salmeterol 25 µg pMDI
  • 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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01344655
CCD-0901-PR-0012
2008-008656-16 ( EudraCT Number )
No
Not Provided
Not Provided
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.
March 2017

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