PT010 Inhaler for Severe Asthma

(LOGOS Trial)

No longer recruiting at 330 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaler combination designed to help people with severe asthma who do not get enough relief from their current treatment. The inhaler contains three medications: budesonide (a corticosteroid), glycopyrronium, and formoterol, which aim to improve breathing and better manage asthma symptoms. The trial includes different groups, each testing a slightly different combination or dosage of these medicines. People who have had asthma for over a year and still experience frequent symptoms despite using their current inhaler might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to access a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have raised safety concerns about the combination of budesonide, glycopyrronium, and formoterol. Reports have noted immediate allergic reactions. Additionally, this combination might increase the risk of worsening asthma, potentially leading to serious outcomes like hospitalization or even death.

Research has shown that the budesonide and formoterol combination is generally well-tolerated. However, there remains a risk of severe asthma attacks, which can be serious. Side effects may include chest pain, a fast or irregular heartbeat, and shaking.

Both combinations have treated conditions like asthma and COPD (a lung disease), indicating some level of established safety. However, potential risks should be considered when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the PT010 inhaler for severe asthma because it combines budesonide, formoterol, and glycopyrronium in a single metered dose inhaler (MDI). This innovative combination targets inflammation, relaxes the airway muscles, and reduces mucus production all at once, which is not typically achieved with standard treatments like Symbicort that lack glycopyrronium. The PT010 inhaler offers two dosage options, potentially allowing for more personalized asthma management. This triple-action approach could provide enhanced control over asthma symptoms, improving the quality of life for patients with severe asthma.

What evidence suggests that this trial's treatments could be effective for severe asthma?

Research has shown that the budesonide/glycopyrronium/formoterol inhaler, a treatment in this trial, can help people with severe asthma. Studies have demonstrated that this combination, known as BGF MDI, improves breathing and quality of life for patients with COPD, a condition similar to asthma. Trials also found that this triple therapy reduces the frequency of asthma attacks. For those whose asthma isn't well-controlled with usual treatments, this inhaler might offer better management. Evidence suggests that these three medicines together help open airways and reduce swelling, making it a promising option for severe asthma. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Wise, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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 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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40513294/

EBISU study

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04609904

NCT04609904 | Study to Assess PT010 in Adult and ...

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212534525000711

Real-world effectiveness of budesonide/glycopyrronium/ ...

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD.

4.

astrazeneca-us.com

astrazeneca-us.com/media/press-releases/2025/Breztri-met-primary-endpoints-in-kalos-and-logos-phase-III-trials-in-asthma.html

BREZTRI met primary endpoints in KALOS and LOGOS ...

The trials evaluated the efficacy and safety of BREZTRI versus maintenance treatment with ICS/LABA in adults and adolescents with uncontrolled asthma.

5.

link.springer.com

link.springer.com/article/10.1007/s12325-025-03361-x

Real-World Outcomes in Patients with COPD Initiating ...

After BGF initiation, the proportions of patients experiencing moderate and severe exacerbations decreased by 20.8% and 23.1%, respectively.

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf

SYMBICORT (budesonide/formoterol fumarate dihydrate)

The overall safety data in adults and adolescents are based upon 10 active- and placebo-controlled clinical trials in which. 3393 patients ages 12 years and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7994217/

Safety of As-Needed Budesonide-Formoterol in Mild Asthma

Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/budesonide-and-formoterol-inhalation-route/description/drg-20068949

Budesonide and formoterol (inhalation route) - Side effects ...

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be ...

9.

symbicorttouchpoints.com

symbicorttouchpoints.com/

SYMBICORT® (budesonide/formoterol fumarate dihydrate ...

Sustained improvement in lung function was demonstrated in a 12-month efficacy and safety study in COPD and a 12-week efficacy and safety study in asthma.3-6. † ...

10.

mysymbicort.com

mysymbicort.com/asthma.html

Asthma Treatment | SYMBICORT® (budesonide/formoterol ...

SYMBICORT may cause serious side effects, including: Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, tremor, increased ...