Trials / Completed
CompletedNCT03836677
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
Detailed description
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds. This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | BGF | Treatment with Budesonide/Glycopyrronium/FormoterolFumarate |
| COMBINATION_PRODUCT | GFF | Treatment with Glycopyrronium/Formoterol Fumarate |
Timeline
- Start date
- 2019-02-26
- Primary completion
- 2019-11-11
- Completion
- 2019-11-11
- First posted
- 2019-02-11
- Last updated
- 2021-02-11
- Results posted
- 2021-02-11
Locations
4 sites across 2 countries: Belgium, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03836677. Inclusion in this directory is not an endorsement.