What side effects are associated with this type of intervention?

Common side effects of inhaled corticosteroids (ICS) like budesonide include oral thrush, hoarseness, and potential systemic effects such as adrenal suppression with long-term use. Long-acting muscarinic antagonists (LAMA) like glycopyrronium can cause dry mouth, urinary retention, and constipation. Long-acting beta-agonists (LABA) like formoterol may lead to tremors, palpitations, and muscle cramps. When combined, these medications generally have a favorable safety profile, but monitoring for these side effects is important.

What prior FDA approvals exist?

The FDA has approved several combination inhalers for the treatment of asthma that include corticosteroids, long-acting muscarinic antagonists (LAMAs), and long-acting beta2-agonists (LABAs). Examples include fluticasone/salmeterol (Advair), budesonide/formoterol (Symbicort), and fluticasone/vilanterol (Breo Ellipta). These combinations work by reducing inflammation (corticosteroids), relaxing airway muscles (LAMAs), and improving breathing (LABAs). The budesonide/glycopyrronium/formoterol inhaler being studied is similar in that it combines these three types of medications to manage asthma symptoms effectively.

What other types of research exist?

Promising alternatives to Budesonide/Glycopyrronium/Formoterol inhaler for asthma patients include: 1) Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UM/VI), which has shown efficacy in improving FEV1 and reducing exacerbations in patients with higher blood eosinophil levels. 2) Beclomethasone/Glycopyrronium/Formoterol, another triple combination inhaler under investigation, which may offer similar benefits in terms of lung function and symptom control.

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Corticosteroid

PT010 Inhaler for Severe Asthma (LOGOS Trial)

Phase 3

Recruiting

Led By Robert Wise, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.

FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.

Must not have

Do you have a known allergic reaction to drugs called beta2-agonists, corticosteroids, anticholinergics, or any component of inhaler formulations?

Do you have an inoperable cancer that has not been in complete remission for at least 5 years?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests an inhaler with three medications to help people with severe asthma who don't respond well to usual treatments. The inhaler reduces inflammation, relaxes muscles around the airways, and keeps them open longer. The study aims to see if this combination is more effective and safe compared to other treatments.

Who is the study for?

Adults and adolescents aged 12 to 80 with severe asthma not well-controlled by standard treatments. Must have been diagnosed with asthma for at least a year, regularly using certain inhaled medications, and meet specific lung function criteria. Excludes current smokers or those who quit recently, people on certain other asthma or immunosuppressive drugs, recent users of oral steroids, and individuals with serious allergies to trial medication components.

What is being tested?

The study is testing the effectiveness of a new inhaler containing budesonide/glycopyrronium/formoterol (BGF) compared to existing therapies for severe asthma. Participants will use one of four different dose combinations of BGF or similar medications over a variable period to see if it better controls their symptoms.

What are the potential side effects?

Potential side effects may include typical reactions associated with inhaled corticosteroids and bronchodilators such as throat irritation, hoarseness, coughing, headaches, increased risk of infections like pneumonia or thrush (a fungal infection in the mouth), tremors and heart palpitations.

Eligibility Criteria

Inclusion Criteria

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

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I have been on a stable daily asthma medication regimen for at least 4 weeks.

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My lung function improved by at least 12% and 200 mL after taking albuterol.

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I am aged 12-17 and have shown a health improvement of 12% before or during the study visits.

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I have been diagnosed with asthma for over a year.

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I have been hospitalized for asthma in the last 2 months.

Exclusion Criteria

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

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I am allergic to certain asthma or COPD medications.

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My cancer is inoperable and has not been in complete remission for 5 years.

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I've been hospitalized for severe asthma needing a breathing tube.

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I have used a long-acting muscarinic antagonist in the last 12 weeks.

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I haven't taken corticosteroids for asthma or respiratory infections in the last 4 weeks.

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I have used steroids like Prednisone in the last 4 weeks.

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I have not used a depot corticosteroid in the last year.

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I currently smoke, or I used to smoke a lot, or I quit smoking less than 6 months ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24

Rate of severe asthma exacerbations

Secondary study objectives

Change from baseline in morning pre-dose trough FEV1 at Week 24

Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1

Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24

+8 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μgExperimental Treatment1 Intervention

BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Group II: BGF MDI 320/14.4/9.6 μgExperimental Treatment1 Intervention

BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Group III: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μgActive Control1 Intervention

BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)

Group IV: Symbicort®Active Control1 Intervention

Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg

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

0 / 13Eligibility 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

Asthma treatments often include a combination of corticosteroids, LAMAs, and LABAs. Corticosteroids, such as budesonide, reduce inflammation in the airways, which helps to prevent asthma attacks and control chronic symptoms. LAMAs, like glycopyrronium, work by relaxing the muscles around the airways, reducing bronchoconstriction and making it easier to breathe. LABAs, such as formoterol, also relax airway muscles but additionally improve overall breathing by increasing airflow and reducing symptoms like wheezing and shortness of breath. These mechanisms are crucial for asthma patients as they address both the inflammatory and bronchoconstrictive components of the disease, leading to better symptom control and improved quality of life.