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Corticosteroid

Combination Inhalers for COPD (THARROS 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
A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70% at V1
Current or former smokers with a history of at least 10 pack-years of cigarette smoking
Must not have
End-stage renal disease requiring renal replacement therapy
Unstable or life-threatening cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial will compare the effect of using a combination inhaler (BGF) containing three types of medication versus a different combination inhaler (GFF) in people with COPD and high risk for

Who is the study for?
This trial is for people with Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of heart and lung complications. Participants should not have other health conditions that could interfere with the study or be using certain medications.Check my eligibility
What is being tested?
The study tests a combination inhaler therapy (BGF MDI) against a dual therapy inhaler (GFF MDI). It aims to see if adding an extra drug to the usual treatment can improve heart and lung function in COPD patients.See study design
What are the potential side effects?
Possible side effects may include throat irritation, hoarseness, dry mouth, coughing, headaches, respiratory infections like pneumonia, and potentially worsened breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with COPD, confirmed by a specific lung function test.
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I have smoked at least 10 pack-years.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis for end-stage kidney disease.
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I do not have a severe heart condition.
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I have been using inhaled corticosteroids regularly for the last year.
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I have been diagnosed with asthma or another chronic lung condition in the last 5 years, but not COPD.
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I have had or am waiting for a heart or lung transplant.
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I do not have a condition, other than heart or lung disease, that could shorten my life to under 5 years.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first severe cardiac or COPD event
Secondary outcome measures
Moderate/severe COPD exacerbation rate
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Time to Myocardial Infarction (MI) hospitalization or cardiac death
+3 more
Other outcome measures
Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death

Trial Design

2Treatment groups
Experimental Treatment
Group I: GFF armExperimental Treatment1 Intervention
GFF MDI 14.4/9.6 μg BID
Group II: BGF armExperimental Treatment1 Intervention
BGF MDI 320/14.4/9.6 μg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGF MDI 320/14.4/9.6 μg
2015
Completed Phase 3
~11120
GFF MDI 14.4/9.6 μg
2015
Completed Phase 3
~9220

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,619,599 Total Patients Enrolled
~3333 spots leftby Mar 2028
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