Trigon: Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT02189577

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

3.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: CHF 5259 Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHF 5259 CHF 5259	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. Other Names: glycopyrrolate bromide
Placebo Comparator: Placebo Placebo	Drug: 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.

Arm

Intervention/Treatment

Experimental: CHF 5259

CHF 5259

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.

Other Names:

glycopyrrolate bromide

Placebo Comparator: Placebo

Placebo

Drug: 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.

Outcome Measures

Primary Outcome Measures

Change from baseline in pre-dose morning FEV1 on Day 28 [Day 28]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chiesi Clinical Trial Site 1017	Sevlievo	Bulgaria
2	Chiesi Clinical Trial Site 1010	Sofia	Bulgaria
3	Chiesi Clinical Trial Site 1011	Sofia	Bulgaria
4	Chiesi Clinical Trial Site 1014	Sofia	Bulgaria
5	Chiesi Clinical Trial Site 1015	Sofia	Bulgaria
6	Chiesi Clinical Trial Site 1016	Sofia	Bulgaria
7	Chiesi Clinical Trial Site 1012	Stara Zagora	Bulgaria
8	Chiesi Clinical Trial Site 1013	Troyan	Bulgaria
9	Chiesi Clinical Trial Site 2024	Berlin	Germany
10	Chiesi Clinical Trial Site 2028	Berlin	Germany
11	Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf	Großhansdorf	Germany	D-22927
12	Chiesi Clinical Trial Site 2027	Hamburg	Germany
13	Chiesi Clinical Trial Site 2026	Leipzig	Germany
14	Chiesi Clinical Trial Site 2023	Magdeburg	Germany
15	Chiesi Clinical Trial Site 2021	Radebeul	Germany
16	Chiesi Clinical Trial Site 2022	Witten	Germany
17	Chiesi Clinical Trial Site 3039	Bydgoszcz	Poland
18	Chiesi Clinical Trial Site 3032	Katowice	Poland
19	Chiesi Clinical Trial Site 3035	Kraków	Poland
20	Chiesi Clinical Trial Site 3037	Lubin	Poland
21	Chiesi Clinical Trial Site 3031	Ostrowiec Świętokrzyski	Poland
22	Chiesi Clinical Trial Site 3033	Oświęcim	Poland
23	Chiesi Clinical Trial Site 3038	Rzeszów	Poland
24	Chiesi Clinical Trial Site 3034	Tarnów	Poland
25	Chiesi Clinical Trial Site 3030	Wrocław	Poland
26	Chiesi Clinical Trial Site 3036	Zgierz	Poland
27	Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus	London	United Kingdom	SW7 2AZ
28	Chiesi Clinical Trial Site 4042	London	United Kingdom
29	Chiesi Clinical Trial Site 4041	Manchester	United Kingdom