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Corticosteroid

Triple-Inhaler Therapy for COPD (ATHLOS Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have a constant work rate test endurance time of 3 to 8 minutes at Visit 2
Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-treatment
Awards & highlights

ATHLOS Trial Summary

This trial looks at the effect of 3 inhalers on lung capacity and exercise endurance.

Who is the study for?
This trial is for adults aged 40-80 with moderate to severe COPD who are current or former smokers. They must have a BMI < 40 kg/m2, stable on COPD treatment for at least 6 weeks, and not be using oxygen therapy or have certain health conditions like untreated glaucoma, significant cancers, or recent drug abuse.Check my eligibility
What is being tested?
The study tests the effects of two inhalers: one with Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF), another with just Budesonide and Formoterol Fumarate (BFF), against a placebo. It measures how these treatments impact breathing capacity and exercise endurance in COPD patients.See study design
What are the potential side effects?
Possible side effects include respiratory infections, throat irritation or pain, coughing, dry mouth from glycopyrronium; potential pneumonia risk from budesonide; tremors or heart palpitations from formoterol fumarate.

ATHLOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can exercise at a steady pace for 3 to 8 minutes.
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I am between 40 and 80 years old.
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I have smoked at least 10 pack-years.
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I have been diagnosed with COPD based on my lung function tests.
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My lung function is moderately to severely reduced.
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I have been on a steady COPD treatment for at least 6 weeks.

ATHLOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in isotime Inspiratory capacity (IC)
Secondary outcome measures
Change from baseline in Isotime dyspnea (NRS)
Change from baseline in RV/TLC
Change from baseline in constant work rate cycle ergometry endurance time
+6 more

ATHLOS Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: BGF MDIActive Control1 Intervention
Pressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation.
Group II: BFF MDIActive Control1 Intervention
Pressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation.
Group III: PlaceboPlacebo Group1 Intervention
Placebo as pressurized inhalation suspension.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,495 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accommodating patients of advanced age?

"To be eligible for this clinical trial, prospective patients must have attained at least 40 years of age and not exceed 80."

Answered by AI

Is it possible to sign up for this experimental venture?

"Candidates between the ages of 40 and 80 with a chronic obstructive pulmonary disease diagnosis can sign up for this clinical trial. The team is seeking to enroll 180 individuals in total."

Answered by AI

Has the research been implemented in multiple Canadian practices?

"The trial is presently recruiting at 22 sites, including Anderson, Greenville and Spartanburg. For those interested in participating, it may be prudent to select the closest medical centre so as to reduce travel difficulty."

Answered by AI

Has the Food and Drug Administration granted authorization for BGF MDI?

"Our organisation's score for BGF MDI is 3 due to the existence of evidence-based support from efficacy testing and multiple safety trials."

Answered by AI

Is this research endeavor actively seeking participants?

"Based on the data hosted by clinicaltrials.gov, this medical trial is not recruiting patients at this point in time. The study was first advertised on October 13th 2023 and last updated on September 28th of that same year. While no one can join the trial now, there are 520 other studies actively enrolling participants presently."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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).
2023. "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).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067828.
All > Copd
~120 spots leftby Aug 2025
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