ATHLOSS
Research type
Research Study
Full title
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 Chronic Obstructive Pulmonary Disease (ATHLOS)
IRAS ID
1007637
Contact name
Behxhet Gashi
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Chronic obstructive pulmonary disease (COPD) is a long-term condition caused by damage to and narrowing of the airways. This can lead to symptoms such as difficulty breathing, coughing and phlegm. These symptoms can make exercising difficult and negatively impact quality of life.
There is no cure for COPD but treatments can help slow progression and control symptoms.
Researchers think the trial treatment budesonide / glycopyrronium / formoterol (BGF) metered dose inhaler (MDI) could make exercise easier for participants by increasing how much air they can breathe. Researchers will compare the results of taking BGF MDI with the results of taking the trial treatment budesonide / formoterol fumarate (BFF) MDI or a placebo MDI to learn if BGF MDI improves breathing and endurance during exercise.
This is a double-blind, crossover trial meaning that none of the participants or researchers will know what treatment each participant is receiving and that all participants will take the same treatments but in a different order. Participants will be in the trial for up to 14 weeks. Participants will take 2 puffs of an inhaler (BGF, BFF or Placebo) twice a day for 12 weeks.
Participants can also use an albuterol rescue inhaler as needed throughout the trial.
Doctors will monitor participants’ health during the trial and participants will be asked to report their symptoms daily using an electronic device.
Participants are not expected to directly benefit from taking part in this trial but they will help researchers learn more about treatments to make exercise easier for people with COPD.
The trial will include up to about 180 participants in 7 countries at 23 sites.
All participants will be between 40 to 80 years old and have COPD with breathlessness even with treatment with their COPD maintenance therapy.
AstraZeneca AB is the Sponsor of this study.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0286
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion