Airsupra for Asthma

(MARC-45 Trial)

Overseen By Carlos A Camargo, MD, DrPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must be taking: Airsupra

Must not be taking: Systemic corticosteroids

Disqualifiers: COPD, Cardiovascular disease, Cancer, others

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

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

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively Airsupra, a rescue inhaler, prevents asthma attacks following an emergency room visit. The researchers aim to determine if starting Airsupra in the ER can reduce asthma flare-ups and improve asthma control over three months. Participants will either receive usual care or use Airsupra as needed. Ideal participants are adults who have recently experienced an asthma attack and have been discharged from the ER with a short course of steroids. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective Airsupra can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be willing to use Airsupra as your rescue inhaler for the next 3 months.

What is the safety track record for Airsupra?

Studies have shown that Airsupra, a combination of albuterol and budesonide, is generally safe for people with asthma. Research indicates that Airsupra significantly reduces the risk of severe asthma attacks compared to albuterol alone. However, some patients might experience worsening asthma or rare, serious breathing problems called paradoxical bronchospasm, an unexpected tightening of the airways.

Airsupra is not intended for children, as its safety and effectiveness have not been tested in younger patients. Prospective trial participants should consult a healthcare provider about any concerns or questions regarding side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Airsupra is unique because it offers a new approach to managing asthma by providing relief as needed, known as "PRN" (pro re nata) use. Unlike traditional treatments like inhaled corticosteroids or long-acting beta-agonists, which often require regular, scheduled doses, Airsupra allows for flexibility in administration. Researchers are excited about its potential to improve convenience and adherence for asthma patients, while still effectively controlling symptoms when they occur.

What is the effectiveness track record for Airsupra in treating asthma?

Research has shown that Airsupra, which participants in this trial may receive, effectively manages asthma. In earlier studies, Airsupra reduced the risk of severe asthma attacks by 46% to 47% compared to albuterol alone. Patients experienced fewer serious asthma issues when using Airsupra. These findings suggest that Airsupra could help people with asthma experience fewer flare-ups and better control their condition. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults aged 18 to 54 with acute asthma, who can use an MDI (inhaler) correctly. They must be discharged from the emergency department on steroids and willing to use Airsupra as a rescue inhaler for three months. Exclusions include recent steroid use, significant heart disease or cancer, no phone/email access, pregnancy/breastfeeding without contraception, other lung diseases like COPD, current serious infections, or participation in another study.

Inclusion Criteria

I am currently experiencing an acute asthma attack.

Demonstration of acceptable MDI administration technique

I am between 18 and 54 years old.

Exclusion Criteria

Involvement in the planning and/or conduct of the study

Previous enrollment in the present study

I have not taken any corticosteroids in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Airsupra PRN and a short course of systemic corticosteroids at intervention sites, or usual care at control sites

3 weeks

1 visit (in-person) for ED discharge

Follow-up

Participants are monitored for acute asthma relapse and asthma control, with follow-up assessments at 3, 6, and 12 weeks after ED discharge

12 weeks

Follow-up via telephone or text at 3, 6, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airsupra

Trial Overview The trial tests if starting Airsupra in the emergency department affects asthma 'recurrence' at three months compared to usual care. It's randomized: by chance some get Airsupra while others don't. The focus is on whether it prevents relapses and improves overall asthma control.

How Is the Trial Designed?

Group I: Usual care Active Control 1 Intervention

usual care

Group II: Intervention Active Control 1 Intervention

Airsupra PRN

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. 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 ... Airsupra demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone.

2. empr.com empr.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 ...

3. 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 ...

4. airsuprapayer.com airsuprapayer.com/clinical-value-profile-of-airsupra

Clinical Value Profile | AIRSUPRA Inhalation Aerosol Key secondary endpoints included the annualized rate of severe asthma exacerbations and annualized total SCS dose. While patients 12 to 17 years old were ...

5. 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– ...

6. airsuprahcp.com airsuprahcp.com/safety

airsupra safety evaluated in clinical trials Patients should be monitored for asthma deterioration · AIRSUPRA can produce life-threatening paradoxical bronchospasm (discontinue as needed) · AIRSUPRA can ...

7. airsuprapayer.com airsuprapayer.com/burden-of-asthma

Burden Of Asthma | For Formulary Decision-Makers The safety and effectiveness of AIRSUPRA have not been established in pediatric patients, and AIRSUPRA is not indicated for use in this population. Most ...

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

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