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

Chiesi Farmaceutici S.p.A.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Atimos®DRUG

Formoterol 12 μg pMDI

Serevent™DRUG

Salmeterol 25 µg pMDI

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Airway Disease Section, NHLI, Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

Respiratory Impedance by Impulse oscillometry

Time frame: from 5 minutes to 8 hours post dose

Secondary Outcomes

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

Data from ClinicalTrials.gov

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