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A Double Blind, Multicentre, Randomised 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 Chronic Obstructive Pulmonary Disease (ATHLOS)

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502274-16-00
Acronym
D5988C00001
Enrollment
160
Registered
2023-09-18
Start date
2023-10-19
Completion date
2026-01-13
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

Isotime Inspiratory Capacity (IC).

Detailed description

Constant work rate cycle ergometry endurance time., Isotime dyspnea: isotime dyspnea Numerical Rating Scale (NRS)., - Static lung volumes: Functional Residual Capacity (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Residual Volume/ Total Lung Capacity (RV/TLC), specific airway conductance (sGaw), and Inspiratory Capacity (IC)., Exercise endurance time: constant work rate cycle ergometry endurance time., - Adverse Events (Serious Adverse Events and Adverse Event Leading to Discontinuation of Study Intervention only) (AEs (SAEs and DAEs only)). - Vital signs.

Interventions

DRUGPlacebo pressurized inhalation suspension
DRUGSALBUTAMOL
DRUGsuspension

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Isotime Inspiratory Capacity (IC).

Secondary

MeasureTime frame
Constant work rate cycle ergometry endurance time., Isotime dyspnea: isotime dyspnea Numerical Rating Scale (NRS)., - Static lung volumes: Functional Residual Capacity (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Residual Volume/ Total Lung Capacity (RV/TLC), specific airway conductance (sGaw), and Inspiratory Capacity (IC)., Exercise endurance time: constant work rate cycle ergometry endurance time., - Adverse Events (Serious Adverse Events and Adverse Event Leading to Discontinuation of Study Intervention only) (AEs (SAEs and DAEs only)). - Vital signs.

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026