Combination Inhalers for COPD (THARROS Trial)

Verified 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

Are you a current or former smoker?

Be older than 18 years old

Must not have

Do you have a history of heart or lung transplant or lung cancer?

Have you experienced pneumonia or COPD exacerbation within the past 8 weeks that has not yet been resolved?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first severe cardiac or COPD event

Secondary study objectives

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 study objectives

Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death