Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
NCT02189577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-10-29
Summary
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
Conditions
Interventions
- 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.
- DRUG
-
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.
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Michael POLKEY, MD · Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2015-02-28
- Completion
- 2015-02-28
Countries
- Bulgaria
- Germany
- Poland
- United Kingdom
Study Locations
More Related Trials
-
Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
NCT01985334 ·Status: COMPLETED ·Phase: PHASE4
-
A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease
NCT03084796 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT02130635 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
NCT00501852 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00570778 ·Status: COMPLETED ·Phase: PHASE2
-
A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
NCT01712516 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
NCT02937584 ·Status: COMPLETED ·Phase: PHASE3
-
A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
NCT01313637 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT00510510 ·Status: COMPLETED ·Phase: PHASE2
-
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
NCT00950807 ·Status: COMPLETED ·Phase: PHASE2
-
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
NCT00376714 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD
NCT01959516 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
NCT00749411 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD
NCT01039675 ·Status: COMPLETED ·Phase: PHASE2
-
28-day Repeat Dose Study of GSK573719
NCT01030965 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT00515502 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
NCT02040597 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
NCT02442206 ·Status: COMPLETED ·Phase: PHASE4
-
CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD
NCT05097014 ·Status: COMPLETED ·Phase: PHASE4
-
A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01316887 ·Status: COMPLETED ·Phase: PHASE3
-
2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients
NCT02579850 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
NCT01387230 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01372410 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT00279019 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
NCT03590379 ·Status: COMPLETED ·Phase: PHASE2