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Corticosteroid

Budesonide, Glycopyrronium, and Formoterol Fumarate for Chronic Obstructive Pulmonary Disease (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 between 40 and 80 years of age?
Have you been diagnosed with COPD (chronic obstructive pulmonary disease)?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to first severe cardiac or copd event.
Awards & highlights

Summary

This trial tests if a triple medication inhaler can improve heart and lung health in high-risk COPD patients better than a dual medication inhaler. Using a single inhaler with three medications has been shown to improve lung function and reduce flare-ups in COPD patients compared to using two medications, but it may increase the risk of pneumonia.

Who is the study for?
This trial is for people with COPD who are at high risk of heart and lung complications. Participants should have a history of exacerbations or evidence of heart disease. They must not be currently experiencing a flare-up or have other significant health issues that could interfere with the study.
What is being tested?
The study tests if Breztri/Trixeo, which combines three types of medication (ICS/LAMA/LABA), can improve heart and lung outcomes better than Bevespi, which combines two medications (LAMA/LABA) in those with COPD at high cardiopulmonary risk.
What are the potential side effects?
Possible side effects include respiratory infections, hoarseness or throat irritation, coughing, dry mouth, muscle cramps, possible pneumonia in patients with COPD, increased intraocular pressure and worsening narrow-angle glaucoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to first severe copd exacerbation event
This trial's timeline: 3 weeks for screening, Varies for treatment, and time to first severe copd exacerbation event for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe cardiopulmonary outcomes in a population with COPD not receiving ICS.
Secondary study objectives
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe COPD exacerbations in a population with COPD not receiving ICS.

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Nasopharyngitis
9%
Influenza
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Peripheral arterial occlusive disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Glycopyrronium and Formoterol FumarateExperimental Treatment0 Interventions
GFF MDI 14.4/9.6 μg
Group II: Budesonide, Glycopyrronium, and Formoterol FumarateExperimental Treatment1 Intervention
BGF MDI 320/14.4/9.6 μg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13050

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include Inhaled Corticosteroids (ICS), Long-Acting Muscarinic Antagonists (LAMA), and Long-Acting Beta Agonists (LABA). ICS work by reducing inflammation in the airways, which helps to decrease swelling and mucus production. LAMAs relax the muscles around the airways, preventing them from tightening and thus reducing airway constriction. LABAs improve airflow by relaxing the bronchial muscles, making it easier to breathe. These mechanisms are important for COPD patients as they collectively improve lung function, alleviate symptoms, and reduce the frequency of exacerbations, leading to better overall disease management.
Dual bronchodilation for the treatment of COPD: From bench to bedside.Symptom variability and control in COPD: Advantages of dual bronchodilation therapy.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,645,749 Total Patients Enrolled
~707 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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