What side effects are associated with this type of intervention?

Common treatments for COPD, such as BGF MDI 320/14.4/9.6 µg (Breztri/Trixeo), which include an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta-agonist (LABA), have known side effects. ICS can cause oral thrush, hoarseness, and an increased risk of pneumonia. LAMA may lead to dry mouth, constipation, and urinary retention. LABA can cause tremors, palpitations, and muscle cramps. Combining these treatments can improve lung function and reduce exacerbations but may also increase the risk of the aforementioned side effects.

What prior FDA approvals exist?

The FDA has approved several combination therapies for the treatment of COPD that are similar to BGF MDI 320/14.4/9.6 µg (Breztri/Trixeo). These include ICS/LABA combinations like fluticasone furoate/vilanterol and LAMA/LABA combinations such as tiotropium/olodaterol and umeclidinium/vilanterol. These therapies work by reducing inflammation (ICS), relaxing airway muscles (LAMA), and improving airflow (LABA). Additionally, fixed-dose combinations like glycopyrrolate/formoterol and aclidinium/formoterol have also been approved, providing comprehensive management of COPD symptoms.

What other types of research exist?

Promising alternatives to BGF MDI 320/14.4/9.6 µg (Breztri/Trixeo) for COPD patients include: 1. Tiotropium-olodaterol combination inhaler, which has shown significant improvements in lung function and health status. 2. Umeclidinium-vilanterol combination inhaler, which has demonstrated greater increases in trough FEV1 and mean peak FEV1 compared to its monocomponents and placebo. 3. Phosphodiesterase 4B inhibitor (BI 1015550), which has shown antifibrotic and immunomodulatory effects, improving forced vital capacity in clinical trials. These alternatives offer different mechanisms of action and have shown promising results in recent studies.

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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

Pivotal Trial

No Placebo-Only Group

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 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

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

Influenza

Nasopharyngitis

Headache

Dysphonia

Urinary tract infection

Arthralgia

Back pain

Chronic obstructive pulmonary disease

Vascular insufficiency

Venous thrombosis limb

Peripheral arterial occlusive disease

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)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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.