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Corticosteroid
Triple-Inhaler Therapy for COPD (ATHLOS Trial)
Tarzana, CA
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.
Must not have
Participants who are enrolled or entering a pulmonary rehabilitation program during the study
Hospitalization due to COPD exacerbation or Oral Corticosteroid use due to exacerbation within the 3 months prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-treatment
Awards & highlights
Pivotal Trial
Summary
This trial looks at the effect of 3 inhalers on lung capacity and exercise endurance.
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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am enrolled in or will join a lung rehab program during the study.
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I was hospitalized or used oral steroids for COPD flare-up in the last 3 months.
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I cannot undergo exercise testing due to health reasons.
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I have a chronic respiratory condition other than COPD.
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My cancer has not been fully cleared for 5 years.
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I use oxygen therapy or my oxygen levels drop below 82% when I exercise.
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I can't stop using my inhaler for 6 hours before lung tests.
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I have had surgery to remove part of my lung or a lung transplant.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in isotime Inspiratory capacity (IC)
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Closest Location:Research Site· Tarzana, CA
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,467 Previous Clinical Trials
290,535,750 Total Patients Enrolled