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NCT01344655 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— Imperial  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01344655
Other study ID # CCD-0901-PR-0012
Secondary ID 2008-008656-16
Status Completed
Phase Phase 4
First received November 29, 2010
Last updated March 28, 2017
Start date April 2011
Est. completion date September 2012

Study information
Verified date March 2017
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atimos®
Formoterol 12 µg pMDI
• Serevent™
Salmeterol 25 µg pMDI
• Placebo
placebo

Locations
Country Name City State
United Kingdom Airway Disease Section, NHLI, Imperial College London London

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Impedance by Impulse oscillometry from 5 minutes to 8 hours post dose
Secondary Exhaled Nitric Oxide from 30 minutes to 8 hours post dose
Secondary Multiple Breath Nitrogen Washout from 30 minutes to 8 hours post dose
Secondary Forced Expiratory Volume in the 1st second from 30 minutes to 8 hours post dose
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