Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: CHF 5259; Drug: Placebo

• Registration Number: NCT02189577
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 5259	CHF 5259	CHF 5259
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in pre-dose morning FEV1 on Day 28	Day 28

Secondary Outcome Measures

Name	Time	Method
Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)	Day 28

Trial Locations

Locations (29)

Chiesi Clinical Trial Site 1017; 🇧🇬 Sevlievo, Bulgaria

Chiesi Clinical Trial Site 1010; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 1011; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 1014; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 1015; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 1016; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 1012; 🇧🇬 Stara Zagora, Bulgaria

Chiesi Clinical Trial Site 1013; 🇧🇬 Troyan, Bulgaria

Chiesi Clinical Trial Site 2024; 🇩🇪 Berlin, Germany

Chiesi Clinical Trial Site 2028; 🇩🇪 Berlin, Germany

Scroll for more (19 remaining)