A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.
NCT04155047 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2021-05-10
Summary
A clinical study to investigate if a single dose of an approved drug product (glycopyrrolate Inhalation Solution) reduces trapped air in the lungs of participants with chronic obstructive pulmonary disease. This study is accepting male and female participants over the age of 40. The study will be conducted at one site located in the United States.
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Interventions
- COMBINATION_PRODUCT
-
Glyocopyrrolate Inhalation Solution administered by Magnair
glycopyrrolate Inhalation Solution 25mcg, single dose
- DRUG
-
Placebo administered by Magnair
Placebo Inhalation Solution
Sponsors & Collaborators
-
Sunovion Respiratory Development Inc.
lead INDUSTRY
Principal Investigators
-
Respiratory Medical Director · Sumitomo Pharma America, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-07
- Primary Completion
- 2020-03-31
- Completion
- 2020-03-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
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 Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.
NCT00519376 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
NCT01005901 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT02294734 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01013142 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
NCT01610037 ·Status: COMPLETED ·Phase: PHASE3
-
A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02182674 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study
NCT01426009 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
NCT02347761 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01706536 ·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.
NCT01727141 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
NCT04600505 ·Status: COMPLETED ·Phase: PHASE1
-
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
NCT00929110 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
NCT01566604 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01922271 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT04600778 ·Status: UNKNOWN ·Phase: PHASE2
-
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 Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD
NCT01636713 ·Status: COMPLETED ·Phase: PHASE3
-
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00422604 ·Status: COMPLETED ·Phase: PHASE2
-
A Crossover Study in the Treatment of Patients With COPD
NCT00462540 ·Status: COMPLETED ·Phase: PHASE3
-
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00676052 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01119950 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
NCT02347774 ·Status: COMPLETED ·Phase: PHASE3
-
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
NCT02268396 ·Status: COMPLETED ·Phase: PHASE3
-
The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
NCT04675463 ·Status: UNKNOWN ·Phase: NA