PT010 Inhaler for Severe Asthma

(LOGOS Trial)

Recruiting in Palo Alto (17 mi)

+274 other locations

Overseen by Robert Wise, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert Wise, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

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

Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1.

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

Exclusion Criteria

I have not used any biologic treatments like omalizumab in the last 3 months.

I am allergic to certain asthma or COPD medications.

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

Treatment Details

Interventions

• Budesonide (Corticosteroid)
• Formoterol (Beta-2 Agonist)
• Glycopyrronium (Anticholinergic)

Trial Overview 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.

Participant Groups

Group I: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg Experimental Treatment 1 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 μg Experimental Treatment 1 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 μg Active Control 1 Intervention

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

Group IV: Symbicort® Active Control 1 Intervention

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

Budesonide is already approved in Canada for the following indications:

Approved in Canada as Pulmicort for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology