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NCT02189577 Clinical Trial

Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— Trigon  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02189577
Other study ID # CCD-05993AA1-09
Secondary ID 2013-005268-25
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2014
Est. completion date February 2015

Study information
Verified date October 2021
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CHF 5259
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
• Placebo
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.

Locations
Country Name City State
Bulgaria 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
Germany Chiesi Clinical Trial Site 2024 Berlin
Germany Chiesi Clinical Trial Site 2028 Berlin
Germany Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf Großhansdorf
Germany Chiesi Clinical Trial Site 2027 Hamburg
Germany Chiesi Clinical Trial Site 2026 Leipzig
Germany Chiesi Clinical Trial Site 2023 Magdeburg
Germany Chiesi Clinical Trial Site 2021 Radebeul
Germany Chiesi Clinical Trial Site 2022 Witten
Poland Chiesi Clinical Trial Site 3039 Bydgoszcz
Poland Chiesi Clinical Trial Site 3032 Katowice
Poland Chiesi Clinical Trial Site 3035 Kraków
Poland Chiesi Clinical Trial Site 3037 Lubin
Poland Chiesi Clinical Trial Site 3031 Ostrowiec Swietokrzyski
Poland Chiesi Clinical Trial Site 3033 Oswiecim
Poland Chiesi Clinical Trial Site 3038 Rzeszów
Poland Chiesi Clinical Trial Site 3034 Tarnów
Poland Chiesi Clinical Trial Site 3030 Wroclaw
Poland Chiesi Clinical Trial Site 3036 Zgierz
United Kingdom Chiesi Clinical Trial Site 4042 London
United Kingdom Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus London
United Kingdom Chiesi Clinical Trial Site 4041 Manchester

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Bulgaria,  Germany,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in pre-dose morning FEV1 on Day 28 Day 28
Secondary 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
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