PT010 Inhaler for Severe Asthma

(LOGOS Trial)

Recruiting at 278 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: ICS/LABA

Must not be taking: Biologics, LAMA, Immunosuppressants, others

Disqualifiers: Smoking, COPD, Life-threatening asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 to 52 weeks

2187 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires participants to adjust their current asthma therapy as needed, and certain medications like LAMA, oral beta2-agonists, and some biologics must not be used during the study. You should discuss your specific medications with the study team to see if any changes are needed.

What data supports the effectiveness of the PT010 inhaler for severe asthma?

Research shows that using a combination of budesonide and formoterol in a single inhaler improves lung function and reduces asthma symptoms more effectively than using budesonide alone. Additionally, combining budesonide with glycopyrronium and formoterol has been shown to improve lung function and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), suggesting potential benefits for severe asthma as well. ^{1 2 3 4 5}

Is the PT010 Inhaler safe for humans?

Research shows that the combination of budesonide and formoterol, which are components of the PT010 Inhaler, has been evaluated for safety in treating asthma. Studies indicate that these medications are generally well-tolerated and safe for use in humans with mild to severe asthma. ^{1 2 6 7 8}

What makes the PT010 inhaler drug unique for severe asthma?

The PT010 inhaler combines three medications—budesonide, formoterol, and glycopyrronium—into a single inhaler, which is unique because it offers a comprehensive approach by including an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist. This combination can improve lung function and reduce asthma symptoms more effectively than using these medications separately or in pairs. ^{1 3 5 6 9}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive budesonide, glycopyrronium, and formoterol fumarate MDI or comparator treatments

24 to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Budesonide
• Formoterol
• Glycopyrronium

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 European Union, United States, Canada for the following indications:

Approved in European Union as Pulmicort for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis
• Crohn's disease
• Ulcerative colitis
• Microscopic colitis
• Eosinophilic esophagitis
• Primary immunoglobulin A nephropathy

Approved in United States as Entocort EC for:

• Crohn's disease
• Ulcerative colitis
• Primary immunoglobulin A nephropathy
• Eosinophilic esophagitis

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

Findings from Research

In a study of 373 patients with moderate persistent asthma, Symbicort (budesonide/formoterol) significantly improved lung function compared to fluticasone propionate, with greater increases in morning peak expiratory flow (PEF) and fewer asthma exacerbations.

Symbicort also led to better overall asthma control, as indicated by a higher percentage of symptom-free days and reduced reliance on reliever medication, while both treatments were well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy with single inhaler budesonide/formoterol compared with high dose of fluticasone propionate alone in patients with moderate persistent asthma. Bateman, ED., Bantje, TA., João Gomes, M., et al.[2019]

In pivotal phase III trials lasting 24-52 weeks, the combination of budesonide, glycopyrronium, and formoterol significantly reduced moderate to severe COPD exacerbations and improved lung function compared to other combinations.

This inhaler was well tolerated and not only improved symptoms like dyspnoea and quality of life but also reduced the risk of all-cause mortality, making it a strong option for patients with inadequately controlled COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide/Glycopyrronium/Formoterol: A Review in COPD. Heo, YA.[2022]

In a study involving 177 adults with persistent asthma, once-daily administration of budesonide Turbuhaler (400 microg) significantly improved lung function (FEV1) and reduced asthma symptoms compared to placebo over a 12-week period.

The treatment was found to be safe, with adverse events being mostly mild or moderate and similar in frequency to those in the placebo group, indicating that budesonide is a viable option for inhaled corticosteroid-naive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily budesonide via Turbuhaler improves symptoms in adults with persistent asthma. Banov, CH., Howland, WC., Lumry, WR.[2006]

In a study of 467 adults with mild-to-moderate asthma, using a single inhaler of low-dose budesonide/formoterol significantly improved morning peak expiratory flow (PEF) compared to a higher dose of budesonide alone, with increases of 16.5 L/min versus 7.3 L/min.

The combination therapy also led to a 26% reduction in the risk of asthma exacerbations and improved the number of symptom-free days and asthma-control days, while showing similar safety profiles between the two treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Lalloo, UG., Malolepszy, J., Kozma, D., et al.[2019]

In a 12-week study involving 338 adults with mild to moderate asthma, the combination of formoterol and budesonide significantly improved pulmonary function and asthma symptoms compared to budesonide alone, with a notable increase in morning peak expiratory flow (PEF).

The combination therapy was also better tolerated than conventional non-corticosteroid treatments, showing fewer incidences of asthma deterioration, making it the safest and most effective option for long-term asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia. Chuchalin, AG., Ovcharenko, SI., Goriachkina, LA., et al.[2015]

In a study of 908 patients with persistent asthma, budesonide/formoterol (Symbicort SMART) was found to be as effective as conventional best practice (CBP) in preventing severe asthma exacerbations, with no significant difference in exacerbation rates between the two groups.

The Symbicort SMART regimen allowed for a significantly lower daily dose of inhaled corticosteroids (ICS) and reduced monthly drug costs compared to CBP, while also improving asthma control as measured by the Asthma Control Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management. Louis, R., Joos, G., Michils, A., et al.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Combination therapy with single inhaler budesonide/formoterol compared with high dose of fluticasone propionate alone in patients with moderate persistent asthma. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Budesonide/Glycopyrronium/Formoterol: A Review in COPD. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: a five-month multicentre Canadian study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Once-daily budesonide via Turbuhaler improves symptoms in adults with persistent asthma. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. [2019]

8. India pubmed.ncbi.nlm.nih.gov

The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia. [2015]

9. India pubmed.ncbi.nlm.nih.gov

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management. [2021]