Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients (Trigon)

Chiesi

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: CHF 5259

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189577

CCD-05993AA1-09

2013-005268-25 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

Full description

A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Enrollment

100 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
Current smokers or ex-smokers
A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7
Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
BDI score ≤ 10
Patients free of exacerbations for at least 1 month

Exclusion criteria

Pregnant or lactating women
Diagnosis of asthma
Patients treated for exacerbations in the 4 weeks prior to screening visit
Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
Known respiratory disorders other than COPD
Patients who have clinically significant cardiovascular condition