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

Chiesi

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Atimos®; Drug: Serevent™; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01344655

CCD-0901-PR-0012

2008-008656-16 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

Formoterol 12 μg pMDI (Atimos®)

Experimental group

Treatment:

Drug: Atimos®

Salmeterol 25 µg pMDI HFA (Serevent™)

Active Comparator group

Treatment:

Drug: Serevent™

Matched Placebo

Placebo Comparator group

Treatment:

Drug: Placebo