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Evaluating the effects of inhalers on exercise in COPD patients

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)

PHASE3 · AstraZeneca · NCT06067828

This study is testing if a new inhaler can help people with COPD exercise better and breathe easier compared to a placebo and another inhaler they may already be using.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment180 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorAstraZeneca (industry)
Locations37 sites (Los Angeles, California and 36 other locations)
Trial IDNCT06067828 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of a metered dose inhaler containing Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) compared to a placebo and another inhaler with Budesonide and Formoterol Fumarate (BFF) on exercise parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD). It is a multicenter, three-treatment, three-period, cross-over design, where participants will be randomized to receive different treatments over a total duration of up to 14 weeks. The primary focus is on measuring isotime inspiratory capacity and exercise endurance time in patients experiencing breathlessness despite existing COPD therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with moderate to severe COPD who experience exertional breathlessness despite current treatment.

Not a fit: Patients with mild COPD or those not currently on stable inhaled maintenance therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve exercise capacity and overall quality of life for patients with COPD.

How similar studies have performed: Previous studies have shown promising results with similar inhaler combinations in improving COPD symptoms, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
* Participant must have:

  * a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) \< 0.7 at Visit 1
  * a post-bronchodilator FEV1 ≥ 30% and \<80% predicted normal (moderate to severe COPD) at Visit 1.
  * a score of ≥ 2 on the modified Medical Research Council at Visit 1.
  * pre-bronchodilator FRC of \> 120% of predicted normal FRC values at Visit 1.
  * a constant work rate test endurance time of 3 to 8 minutes at Visit 2.
* Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking
* Body mass index \< 40 kg/m2.
* Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception.

Exclusion Criteria:

* A current diagnosis of asthma, asthma- COPD-overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease and pulmonary hypertension.
* Historical or current evidence of a clinically significant disease
* Participants on oxygen therapy or that desaturate significantly (\<82%) during exercise.
* Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
* Participants who have cancer that has not been in complete remission for at least 5 years.
* Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator.
* Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
* Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler.
* Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
* A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1.
* Participants with contraindications to cardiopulmonary exercise testing (CPET).
* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period.
* Participants with lung lobectomy, lung volume reduction or lung transplantation.
* Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit.
* Known history of drug or alcohol abuse within 12 months.
* Any regular recreational use of marijuana in the 12 months.

Where this trial is running

Los Angeles, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Obstructive Pulmonary Disease, Metered Dose Inhalers

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.