New Propellant Inhaler for Asthma

Recruiting at 122 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

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.

What data supports the idea that New Propellant Inhaler for Asthma is an effective treatment?

The available research shows that the New Propellant Inhaler for Asthma, known as Airsupra, combines two components to help treat asthma attacks. While the specific studies provided do not directly compare Airsupra to other treatments, they highlight the importance of combining medications for effective asthma management. For example, the combination of inhaled corticosteroids and long-acting beta agonists is recommended for asthma treatment, as seen in other studies. This suggests that Airsupra, which combines albuterol and budesonide, could be effective in managing asthma symptoms. ^{1 2 3 4 5}

What safety data is available for the new asthma inhaler treatment?

The long-term safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) was evaluated in a 52-week double-blind study involving patients with moderate to severe persistent asthma. The study found that the incidence of adverse events was similar across treatment groups, with common drug-related adverse events being oral candidiasis, tremor, and pharyngolaryngeal pain. No clinically meaningful differences in laboratory, electrocardiogram, or Holter monitor variables were observed. The study also reported a lower incidence of asthma exacerbations with budesonide/formoterol compared to budesonide alone. ^{2 6 7 8 9}

Is the drug BDA (Airsupra, PT027, Albuterol/Budesonide) a promising treatment for asthma?

Yes, BDA is a promising treatment for asthma because it combines albuterol, which helps open airways quickly, and budesonide, which reduces inflammation in the lungs. This combination can improve breathing and provide relief for asthma patients. ^{10 11 12 13 14}

Eligibility Criteria

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 am 18 years old or older.

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• BDA (Corticosteroid)

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.

Participant Groups

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

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

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

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

New Combination Asthma Drug. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Inhaled beclometasone dipropionate/formoterol fumarate extrafine fixed combination for the treatment of asthma. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of budesonide/formoterol in a single inhaler. [2018]

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

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

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Therapeutic potential of glucocorticoids inhalation in bronchial asthma]. [2013]

7. Switzerland 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. [2021]

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

Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide. [2007]

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

Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. [2022]

10. England 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. [2016]

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

Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma. [2019]

12. England 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. [2018]

13. England pubmed.ncbi.nlm.nih.gov

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

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

Clinical comparability of albuterol delivered by the breath-actuated inhaler (Spiros) and albuterol by MDI in patients with asthma. [2013]