Clinical trial NCT02189577: Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary disease
COPD
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in pre-dose morning FEV1 on Day 28
timeFrame: Day 28
Secondary outcomes:
measure: 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)
timeFrame: Day 28
Other outcomes:
Locations:
city: Sevlievo
country: Bulgaria
facility: Chiesi Clinical Trial Site 1017
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 1010
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 1011
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 1014
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 1015
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 1016
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial Site 1012
city: Troyan
country: Bulgaria
facility: Chiesi Clinical Trial Site 1013
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 2024
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 2028
city: Großhansdorf
country: Germany
facility: Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial Site 2027
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 2026
city: Magdeburg
country: Germany
facility: Chiesi Clinical Trial Site 2023
city: Radebeul
country: Germany
facility: Chiesi Clinical Trial Site 2021
city: Witten
country: Germany
facility: Chiesi Clinical Trial Site 2022
city: Bydgoszcz
country: Poland
facility: Chiesi Clinical Trial Site 3039
city: Katowice
country: Poland
facility: Chiesi Clinical Trial Site 3032
city: Kraków
country: Poland
facility: Chiesi Clinical Trial Site 3035
city: Lubin
country: Poland
facility: Chiesi Clinical Trial Site 3037
city: Ostrowiec Świętokrzyski
country: Poland
facility: Chiesi Clinical Trial Site 3031
city: Oświęcim
country: Poland
facility: Chiesi Clinical Trial Site 3033
city: Rzeszów
country: Poland
facility: Chiesi Clinical Trial Site 3038
city: Tarnów
country: Poland
facility: Chiesi Clinical Trial Site 3034
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial Site 3030
city: Zgierz
country: Poland
facility: Chiesi Clinical Trial Site 3036
city: London
country: United Kingdom
facility: Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
city: London
country: United Kingdom
facility: Chiesi Clinical Trial Site 4042
city: Manchester
country: United Kingdom
facility: Chiesi Clinical Trial Site 4041
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
name: Michael POLKEY, MD
role: PRINCIPAL_INVESTIGATOR
References: