Trials / Completed
CompletedNCT06067828
A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).
A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 171 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
Detailed description
This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy. Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate | Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID). |
| DRUG | Treatment B: Budesonide and Formoterol Fumarate | Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID. |
| DRUG | Treatment C : Placebo | Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID. |
Timeline
- Start date
- 2023-10-24
- Primary completion
- 2026-01-22
- Completion
- 2026-01-22
- First posted
- 2023-10-05
- Last updated
- 2026-03-05
Locations
33 sites across 7 countries: United States, Canada, China, Germany, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06067828. Inclusion in this directory is not an endorsement.