Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
Phase 4
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Atimos®Drug: Serevent™Drug: Placebo
- Registration Number
- NCT01344655
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formoterol 12 μg pMDI (Atimos®) Atimos® - Salmeterol 25 µg pMDI HFA (Serevent™) Serevent™ - Matched Placebo Placebo -
- Primary Outcome Measures
Name Time Method Respiratory Impedance by Impulse oscillometry from 5 minutes to 8 hours post dose
- Secondary Outcome Measures
Name Time Method Exhaled Nitric Oxide from 30 minutes to 8 hours post dose Multiple Breath Nitrogen Washout from 30 minutes to 8 hours post dose Forced Expiratory Volume in the 1st second from 30 minutes to 8 hours post dose
Trial Locations
- Locations (1)
Airway Disease Section, NHLI, Imperial College London
🇬🇧London, United Kingdom