New Propellant Inhaler for Asthma

Recruiting at 119 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Low-dose ICS, ICS-LABA

Must not be taking: Systemic corticosteroids

Disqualifiers: COPD, Life-threatening asthma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

398 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaler propellant for asthma treatment to determine its effectiveness compared to the current one. The focus is on the combination therapy BDA (also known as Airsupra or PT027, which includes Albuterol and Budesonide) to manage asthma symptoms. Participants will receive either the new inhaler, the current inhaler, or a placebo (a non-active treatment) to compare effectiveness. Individuals with asthma for at least a year, who experience regular symptoms and are on low-dose maintenance therapy, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in asthma treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, participants must be willing to adjust their current asthma therapy as required by the protocol. If you are on low-dose ICS or ICS-LABA therapy, you need to be stable on it for a minimum of 3 or 6 months, respectively, before the trial.

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

Research shows that the BDA inhaler, whether using the HFO or HFA propellant, is generally easy for people to use without problems. Studies have linked this combination of budesonide and albuterol to fewer severe asthma attacks compared to albuterol alone, suggesting that patients using the BDA inhaler may experience fewer serious asthma issues.

The BDA inhaler with the HFO propellant is being tested to determine if it works as well as the HFA version. The HFA version is already approved in the U.S. for asthma, indicating its known safety. This approval provides some confidence in its safety for users.

Both inhalers are part of ongoing research to ensure their safety and effectiveness for people with asthma. So far, studies suggest that both versions are safe for use, with no major side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Researchers are excited about the new propellant inhaler for asthma because it uses HFO, a more environmentally friendly propellant, compared to the conventional HFA. This inhaler combines budesonide and albuterol, two well-known medications, but with the innovative twist of the HFO propellant. While traditional inhalers for asthma often rely on HFA propellants, this new inhaler aims to deliver the same effectiveness in treating asthma symptoms while reducing the environmental impact.

What evidence suggests that this new propellant inhaler is effective for asthma?

Research has shown that a combination of budesonide and albuterol (BDA) effectively treats asthma. Studies have found that using albuterol–budesonide as needed can significantly reduce the risk of severe asthma attacks. One study showed that this treatment lowered the chance of a severe attack by up to 47%. This combination is well-regarded for effectively managing asthma symptoms. In this trial, participants will receive BDA inhalers with either HFO or HFA propellants, both designed to provide similar benefits in controlling asthma. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with asthma. Participants should be stable on their current asthma medications and have a history of the disease. Specific details about inclusion or exclusion criteria are not provided, but typically these would cover age range, severity of asthma, and any other health conditions that might affect safety or results.

Inclusion Criteria

Participants must be able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update

I have been diagnosed with asthma by a doctor for at least a year.

I am not on daily asthma medication or only use low-dose inhalers and have been stable for months.

Exclusion Criteria

My cancer cannot be removed by surgery and has not been in complete remission for 5 years.

I have been diagnosed with COPD or another serious lung condition.

I do not have any major health issues that could make this study unsafe for me.

Timeline for a Trial Participant

Screening and Placebo Run-in

Participants are screened for eligibility to participate in the trial and undergo a placebo run-in period

2 weeks

2 visits (in-person)

Treatment

Participants receive the study medication in 3 treatment periods of 4 weeks each

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (telephone contact)

What Are the Treatments Tested in This Trial?

Interventions

• BDA

Trial Overview The study is testing the effectiveness of an approved asthma medication (BDA) using a new propellant (HFO), compared to the same medication with its current propellant (HFA). The goal is to see if lung function remains consistent when switching propellants in inhalers.

How Is the Trial Designed?

Group I: BDA MDI HFO Active Control 1 Intervention

160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO

Group II: BDA MDI HFA Active Control 1 Intervention

160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA

Group III: Placebo MDI HFA Placebo Group 1 Intervention

Placebo pressurized inhalation suspension, HFA

BDA is already approved in United States for the following indications:

Approved in United States as Airsupra for:

• As-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older

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 study involving 60 patients with mild-to-moderate asthma, the breath-actuated albuterol powder inhaler (DPI) was found to be therapeutically comparable to the conventional metered dose inhaler (MDI) in delivering albuterol, with no significant differences in lung function measurements like FEV1.

Both inhalers showed similar safety profiles, affecting serum potassium levels, QTc interval, blood pressure, and heart rate in comparable ways, indicating that the new inhaler is a safe alternative for asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical comparability of albuterol delivered by the breath-actuated inhaler (Spiros) and albuterol by MDI in patients with asthma. Geoffroy, P., Lalonde, RL., Ahrens, R., et al.[2013]

A study analyzing 230 spontaneous reports of adverse drug reactions (ADRs) from inhaled medications for chronic lung diseases revealed that most ADRs were serious and primarily affected non-elderly adults (39.1%).

The inhaled corticosteroid/long-acting beta-2 agonist combination was the most frequently reported, accounting for 32.2% of reports, with respiratory issues like dyspnea being the most common ADR, indicating a need for careful monitoring of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System. Fonseca, W., Monteiro, C., Taborda-Barata, L.[2021]

In a study involving 7241 patients with mild-to-moderate persistent asthma, low-dose budesonide (400 microg daily) did not negatively impact pregnancy outcomes compared to a placebo, with healthy children delivered in 81% of pregnancies in the budesonide group versus 77% in the placebo group.

Among the 196 pregnancies in the budesonide group, 19% had adverse outcomes, while 23% of pregnancies in the placebo group experienced adverse outcomes, suggesting that budesonide may be a safer option during pregnancy for women with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide. Silverman, M., Sheffer, A., Diaz, PV., et al.[2007]

Inhaled therapy, particularly the combination of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA), is essential for effective asthma management, as recommended by international guidelines.

The fixed combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) is unique as it is available in both pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI), which may enhance drug delivery to the peripheral airways, improving treatment outcomes for asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled beclometasone dipropionate/formoterol fumarate extrafine fixed combination for the treatment of asthma. Crisafulli, E., Zanini, A., Pisi, G., et al.[2018]

In a study involving 147 adults with mild-to-moderate persistent asthma, the inhaled corticosteroid budesonide delivered by metered-dose inhaler significantly improved lung function, as measured by morning trough FEV1 and peak expiratory flow rates, particularly at higher doses of 320 μg and 160 μg.

All doses of budesonide were well tolerated and reduced the need for rescue medication, indicating both efficacy and safety, which supports further investigation of the higher doses in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma. Miller, SD., Nyberg, J., Siddiqui, S., et al.[2019]

The transition from chlorofluorocarbons (CFCs) to hydrofluoroalkanes (HFAs) in aerosol propellants has allowed for better design of inhalers, enhancing the delivery of asthma medications to both small and large airways.

The aerosol system using beclomethasone dipropionate in HFA propellant (Qvar) aims to improve the therapeutic ratio, meaning it seeks to maximize the effectiveness of the medication while minimizing systemic side effects for asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing drug delivery to the lung: design of a CFC-free corticosteroid metered-dose aerosol system. Donnell, D.[2019]

In a study involving 40 adult asthmatics, the pressurized metered-dose inhaler (pMDI) with extra-fine particles (FORM/BDP) showed a greater improvement in lung function compared to the pMDI with non-extra-fine particles (FORM/BUD), although overall treatment outcomes were similar between the two.

Patient preferences indicated that while FORM/BDP was perceived to have a higher flume velocity and was more effective in reaching the trachea and bronchus, it also caused more irritation than FORM/BUD, highlighting the importance of patient experience in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial. Nam, TH., Kang, SY., Lee, SM., et al.[2022]

Inhalation glucocorticoids, such as budesonide and beklometasone dipropionate, are clinically effective in treating bronchial asthma, significantly reducing the need for short-acting beta-2-adrenomimetics and decreasing episodes of asphyxia over a 9-month treatment period with 19 patients.

The treatment showed a significant improvement in bronchial permeability after 3 months, and there were no negative effects on hydrocortisone levels, mineral metabolism, or bone density, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic potential of glucocorticoids inhalation in bronchial asthma]. Emel'ianov, AV., Shevelev, SE., Amosov, VI., et al.[2013]

A Phase III study involving 159 children aged 6-12 with mild to moderate asthma showed that the new hydrofluoroalkane (HFA) formulation of budesonide is non-inferior to the conventional chlorofluorocarbon (CFC) formulation in improving lung function, as measured by forced expiratory volume in 1 second (FEV1).

Both formulations of budesonide were well tolerated, with similar rates of adverse events and no cases of oral candidiasis reported, indicating that the HFA formulation is a safe alternative for pediatric asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical comparability between the CFC and HFA budesonide pressurised metered-dose inhalers in paediatric patients with asthma: a randomised controlled trial. Escribano, A., Tutuncu, A., Löhr, I., et al.[2016]

In a study involving 640 patients with severe persistent asthma, fluticasone propionate (Fp) delivered via a novel multidose dry powder inhaler (MDPI) showed improvements in morning peak expiratory flow (PEF) compared to placebo, indicating its efficacy in managing asthma symptoms.

The safety profile of Fp MDPI was similar to that of the traditional Fp dry powder inhaler (DPI), with no new safety concerns identified, suggesting that Fp MDPI is a safe alternative for asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and dose response of fluticasone propionate delivered via the novel MDPI in patients with severe asthma: A randomized, controlled, dose-ranging study. Bernstein, DI., Gillespie, M., Song, S., et al.[2018]

In a 52-week study involving 708 patients with moderate to severe asthma, the combination of budesonide/formoterol showed a significantly lower rate of asthma exacerbations compared to budesonide alone, indicating improved efficacy in asthma management.

The safety profile of budesonide/formoterol was acceptable, with no significant differences in adverse events or clinical abnormalities compared to budesonide, suggesting that adding a long-acting beta(2)-adrenergic agonist (LABA) to inhaled corticosteroids (ICSs) is safe for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. Peters, SP., Prenner, BM., Mezzanotte, WS., et al.[2022]

Airsupra, a new asthma medication, effectively combines albuterol (a short-acting bronchodilator) with budesonide (a corticosteroid) to manage acute asthma attacks.

Patients are advised to continue their regular asthma maintenance therapy even when using Airsupra, ensuring comprehensive asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Combination Asthma Drug. Aschenbrenner, DS.[2023]

Budesonide/formoterol (BUD/FORM) in a fixed dose is significantly more effective than budesonide (ICS alone) in reducing treatment failure rates in adults with moderate to severe asthma, with a 50% increased risk of treatment failure associated with budesonide.

Adjustable maintenance dosing of BUD/FORM shows advantages over fixed dosing, including a 28% reduced risk of hospitalizations and a 19% reduced risk of needing oral steroids, highlighting its potential for better management of asthma exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of budesonide/formoterol in a single inhaler. Edwards, SJ., Gruffydd-Jones, K., Ryan, DP.[2018]

In a case study of three adults with severe persistent asthma, switching to nebulized budesonide inhalation suspension (BIS) significantly improved asthma control, as evidenced by increased peak expiratory flow (PEF) and reduced healthcare visits and oral corticosteroid use over a 5-year period.

BIS may be particularly beneficial for patients who struggle with inhaler techniques or adherence, suggesting that nebulized therapy could be a valuable alternative for those not responding well to traditional inhaled corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of previously uncontrolled adult asthma with budesonide inhalation suspension: five-year case histories. Gawchik, SM.[2007]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504544

As-Needed Albuterol–Budesonide in Mild Asthma In this trial, as-needed use of albuterol–budesonide resulted in a lower risk of a severe asthma exacerbation than as-needed use of albuterol ...

2. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2025/statistically-significant-clinically-meaningful-batura-phase-iii-trial-provide-evidence-airsupra-standard-care-as-needed-rescue-treatment-asthma.html

Statistically significant and clinically meaningful BATURA ... The BATURA trial demonstrated treatment with Airsupra significantly reduced the risk of a severe exacerbation by 47% (5.1%, 9.1%, hazard ratio [ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11348984/

The BATURA Study Design - PMC - PubMed Central - NIH This reduction is supported by results from the MANDALA study, in which the risk of a severe exacerbation was reduced by 27% with albuterol– ...

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html

AIRSUPRA ® (albuterol/budesonide) US prescribing ... The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95 ...

5. pulmonologyadvisor.com pulmonologyadvisor.com/news/airsupra-label-updated-to-include-data-on-use-in-mild-asthma/

Airsupra Label Updated to Include Data on Use in Mild ... Findings showed treatment with Airsupra significantly reduced the risk of a first severe asthma exacerbation by 46% compared with albuterol 180 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03769090

NCT03769090 | A Study to Assess the Efficacy and Safety ... This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time ...

7. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6934C00001

Evaluating the Efficacy and Safety of PT027 Compared ... The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), ...

8. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html

Airsupra (PT027) approved in the US for asthma Compared with albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p< ...