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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

THARROS Trial Summary

This trial aims to show that using a combination inhaler called Breztri/Trixeo can improve heart and lung health in people with COPD and high risk factors compared to using a different inhal

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.Check my eligibility

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.See study design

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.

THARROS Trial Eligibility Criteria

Inclusion Criteria

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

THARROS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time to first severe copd exacerbation event

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Nasopharyngitis

Influenza

Headache

Dysphonia

Urinary tract infection

Arthralgia

Back pain

Chronic obstructive pulmonary disease

Venous thrombosis limb

Peripheral arterial occlusive disease

Vascular insufficiency

Acute myocardial infarction

Cor pulmonale

Nodal arrhythmia

Pneumonia

Hip fracture

Hepatocellular carcinoma

Acute pulmonary oedema

Bradycardia

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Fluticasone / Salmeterol (B)

Budesonide / Indacaterol (A)

THARROS 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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,592,726 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this medical study?

"Eligible candidates for this research must be aged between 40 and 130 years old and have a medical history of chronic obstructive pulmonary disease. A total of 1060 individuals will be enrolled in this investigation."

Answered by AI

What is the current number of individuals participating in this research endeavor?

"Yes, information on clinicaltrials.gov indicates that this medical study is actively seeking participants. Initially shared on January 1st, 2024, the trial's most recent update was made on January 12th of the same year. The research aims to enroll 1060 individuals at a single site."

Answered by AI

Is the medical trial open to individuals younger than 40 years old?

"Enrollment is open to individuals aged 40 and older, up to a maximum of 130 years old."

Answered by AI

Are there any current opportunities for potential participants to enroll in this trial?

"Indeed, as per clinicaltrials.gov data, this trial is actively seeking candidates. Originally shared on January 1st, 2024, and most recently revised on January 12th of the same year. The study aims to enroll 1060 participants at a single site."

Answered by AI

Have Budesonide, Glycopyrronium, and Formoterol Fumarate received approval from the FDA for medical use?

"Based on our assessment at Power, the safety rating for Budesonide, Glycopyrronium, and Formoterol Fumarate is a 3. This evaluation considers existing efficacy data and robust safety information from prior study phases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Efficacy of Breztri/Trixeo on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

2024. "A Study Evaluating the Efficacy of Breztri/Trixeo on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease ". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/BDC00001.

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