Exacerbation Study (BATURA)

AIRSUPRA® (albuterol/budesonide) Inhalation Aerosol is a combination of albuterol, a beta2-adrenergic agonist and budesonide, a corticosteroid, and is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.1

BATURA

Study Design2,3

Phase IIIb, randomized, double-blind, fully virtual, patient-centric, event-driven exacerbation study conducted for up to 52 weeks (minimum 12 weeks) that evaluated efficacy and safety of as-needed albuterol/budesonide versus as-needed albuterol in patients with mild asthma.

Clinical Trials MANDALA Graphic
Clinical Trials MANDALA Graphic

Primary Endpoint

  • Time to first severe exacerbation

Key Secondary Endpoints

  • Annualized rate of severe exacerbations

  • Annualized total systemic corticosteroid dose

Post Hoc Analysis

Patient Population (N=2421)

  • ≥12 years old

  • Asthma previously treated with:

  • SABA alone (as-needed),† or

  • SABA (as-needed) plus low-dose maintenance ICS or LTRA†

Inclusion/Exclusion Criteria

While patients 12 to 17 years old were included in BATURA, AIRSUPRA is not approved in this age group; therefore, efficacy results are only presented for adults ≥18 years of age.

Adult Efficacy Population (n=2353)4

BATURA Key Demographics Chart
BATURA Key Demographics Chart
BATURA Key Clinical Parameters Chart
BATURA Key Clinical Parameters Chart

*Study medication was administered via pMDI in 2 actuations of albuterol/budesonide 90/80 mcg or albuterol 90 mcg, up to a maximum of 12 inhalations per day.2

†SABA alone: ≥2 filled prescriptions for SABA; SABA plus low-dose ICS: ≥1 filled prescription for SABA and ≥1 filled prescription for low-dose ICS; SABA plus LTRA: ≥1 filled prescription for SABA and ≥1 filled prescription for LTRA.2

‡Included Asian, American Indian/Alaska Native, Native Hawaiian/other Pacific Islander, multiple races, not reported, and other.

Primary Endpoint: Time to First Severe Exacerbation3§

BATURA Severe Exacerbation Graph
BATURA Severe Exacerbation Graph
zoom-cta

Albuterol/budesonide 180/160 mcg demonstrated a significant

46 Percentage Reduction In Exacerbation

reduction in risk of severe exacerbation vs albuterol (HR, 0.54; 95% CI: 0.40, 0.72; P<0.001)

Data shown for albuterol/budesonide 180/160 mcg and albuterol 180 mcg are for patients ≥18 years old. Data are from the on-treatment efficacy population and included data collected while on randomized treatment prior to treatment discontinuation or a step-up in maintenance therapy with censoring of data at time of discontinuation or step-up in maintenance therapy.3

§Cox proportional hazards regression model adjusted for treatment, pre-study asthma therapy (SABA only, low-dose ICS plus SABA, LTRA plus SABA), and number of severe exacerbations (0, ≥1) in the 12 months prior to screening.5

Albuterol/budesonide 180/160 mcg demonstrated a significant

46 Percentage Reduction In Exacerbation

reduction in risk of severe exacerbation vs albuterol (HR, 0.54; 95% CI: 0.40, 0.72; P<0.001)

Key Secondary Endpoints

Annualized Severe Exacerbation Rate3║

BATURA Annualized Severe Exacerbation Rate Graph
BATURA Annualized Severe Exacerbation Rate Graph

Annualized Systemic Corticosteroid Dose3¶

BATURA Annualized Systemic Corticosteroid Dose Graph
BATURA Annualized Systemic Corticosteroid Dose Graph

6% of adults on AIRSUPRA 180/160 mcg and 11% of adults on albuterol 180 mcg received SCS due to asthma.1

Data shown for albuterol/budesonide 180/160 mcg and albuterol 180 mcg are for patients ≥18 years old. Data are from the on-treatment efficacy population and included data collected while on randomized treatment prior to treatment discontinuation or a step-up in maintenance therapy with censoring of data at time of discontinuation or step-up in maintenance therapy.3

║There were 82 severe exacerbations in the albuterol/budesonide 180/160 mcg group and 159 in the albuterol 180 mcg group.3

Prednisone equivalent.3

Safety in the Overall BATURA Population

Common adverse reactions reported4

Safety Summary Adverse Reactions Chart in BATURA
Safety Summary Adverse Reactions Chart in BATURA

Data shown for albuterol/budesonide 180/160 mcg and albuterol 180 mcg are for patients ≥12 years old. AIRSUPRA is not approved for patients 12 to 17 years of age.

BATURA results publication: As-needed albuterol–budesonide in mild asthma

New England Journal of Medicine, 2025

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Learn more about AIRSUPRA

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AstraZeneca recommends use of AIRSUPRA only in accordance with its approved Prescribing Information.1

Specialist Perspective

Reframing Rescue Therapy

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Primary Care Perspective

Shifting to ICS Rescue Therapy

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Challenges in asthma care

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Exacerbation study for a rescue therapy (moderate to severe asthma)

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Lung function study for a rescue therapy

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Additional resources and learning

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AIRQ®, Asthma Impairment and Risk Questionnaire; CI, confidence interval; HR, hazard ratio; ICS, inhaled corticosteroid; LTRA, leukotriene receptor antagonist; RR, rate ratio; SABA, short-acting β2-agonist; SCS, systemic corticosteroid; SD, standard deviation.

References:

1. AIRSUPRA® (albuterol/budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. LaForce C, Albers FC, Cooper M, et al. A fully decentralized randomized controlled study of as-needed albuterol–budesonide fixed-dose inhaler in mild asthma: the BATURA study design. J Asthma Allergy. 2024;17:801-811. doi:10.2147/JAA.S471134. 3. LaForce C, Albers F, Danilewicz A, et al. As-needed albuterol–budesonide in mild asthma. N Engl J Med. Published online May 19, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2504544. 4. Data on File, REF-267550, AstraZeneca Pharmaceuticals LP. 5. LaForce C, Albers FC, Danilewicz A, et al. BATURA: a fully virtual randomized controlled study of as-needed albuterol–budesonide versus albuterol in mild asthma. Presented at: American College of Allergy, Asthma & Immunology Annual Scientific Meeting; October 24-28, 2024; Boston, MA. Presentation LBA004.

 

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Important Information for the Healthcare Professional

This study discusses some information about AIRSUPRA® (albuterol 90 mcg/budesonide 80 mcg) that is not contained in or consistent with the FDA-approved Prescribing Information.

AstraZeneca and Avillion executed a Co-Development Agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma: AstraZeneca manufactures and markets AIRSUPRA while Avillion was the clinical trial Sponsor and provided funding for MANDALA. Some authors may have a financial interest in either AIRSUPRA or AstraZeneca/Avillion and/or may have received compensation from AstraZeneca/Avillion in connection with this study or other engagements. AstraZeneca recommends use of AIRSUPRA only in accordance with its approved Prescribing Information. In connection with the discussions contained in the reprint, please note:

  • The study evaluated efficacy and safety for patients ≥4 years old. Only patients ≥12 years old received the approved dosage of AIRSUPRA (albuterol/budesonide 180/160 mcg). While patients <18 years old were included in MANDALA, AIRSUPRA is not approved for this age group.
  • The study assessed an albuterol/budesonide MDI 180/80 mcg as needed arm. This is not an approved dose.
  • This prespecified exploratory analysis from MANDALA evaluated asthma deterioration and the effect of as-needed albuterol/budesonide on progression from deterioration to a severe exacerbation.
  • A post hoc analysis evaluated albuterol/budesonide 180/160 mcg in patients ≥18 years old (FDA-approved population).
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BATURA Severe Exacerbation Graph

BATURA: Select Inclusion and Exclusion Criteria2

Key Inclusion Criteria:

  • Diagnosis of asthma

  • Use of SABA alone or SABA plus a background of either low-dose ICS or LTRA*

  • ≥2 SABA uses for symptoms within 2 weeks prior to enrollment

  • AIRQ® score ≥2 at baseline, indicating uncontrolled disease†

Key Exclusion Criteria:

  • Significant lung disease other than asthma or any other significant disease

  • Hospitalization due to asthma in the 3 months prior to enrollment or ICU admission with life-threatening asthma at any time

  • Use of LABA, theophylline, anticholinergics, cromone, or medium-/high-dose ICS daily as regular maintenance therapy in the 3 months prior to enrollment

  • Use of SCS in the 6 weeks prior to enrollment

While patients 12 to 17 years old were included in BATURA, AIRSUPRA is not approved in this age group; therefore, efficacy results are only presented for adults ≥18 years of age.

*SABA alone: ≥2 filled prescriptions for SABA, SABA + low-dose ICS: ≥1 filled prescription for SABA and ≥1 filled prescription for low-dose ICS; SABA + LTRA: ≥1 filled prescription for SABA and ≥1 filled prescription for LTRA.2

†AIRQ® is a validated 10-item tool to assess symptom impairment and exacerbation risk domains of asthma control in patients ≥12 years. A score of 0-1 is well controlled, score of 2-4 is not well controlled, and score of 5-10 is very poorly controlled.2

AIRQ®, Asthma Impairment and Risk Questionnaire; ICS, inhaled corticosteroid; ICU, intensive care unit; LABA, long-acting β2-agonist; LTRA, leukotriene receptor antagonist; SABA, short-acting β2-agonist; SCS, systemic corticosteroid.

Severe Exacerbation2

In the BATURA trial, an exacerbation was considered severe if it resulted in at least one of the following:

  • a temporary bolus/burst of SCS for ≥3 consecutive days (or a single depo-injectable dose of corticosteroids) to treat symptoms of asthma worsening

  • an emergency room or urgent care visit due to asthma that required SCS (as per the above)

  • inpatient hospitalization due to asthma

  • death

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You are about to leave RethinkingAsthmaRescue.com
Important Information for the Healthcare Professional

This study discusses some information about AIRSUPRA® (albuterol 90 mcg/budesonide 80 mcg) that is not contained in or consistent with the FDA-approved Prescribing Information.

AstraZeneca and Avillion executed a Co-Development Agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma: AstraZeneca manufactures and markets AIRSUPRA while Avillion was the clinical trial Sponsor and provided funding for BATURA. Some authors may have a financial interest in either AIRSUPRA or AstraZeneca/Avillion and/or may have received compensation from AstraZeneca/Avillion in connection with this study or other engagements. AstraZeneca recommends use of AIRSUPRA only in accordance with its approved Prescribing Information. In connection with the discussions contained in the reprint, please note:

  • While patients 12 to 17 years old were included in BATURA, AIRSUPRA is not approved for this age group. AIRSUPRA is indicated only for patients 18 years of age and older.
  • The primary efficacy analysis in BATURA was a preplanned on-treatment analysis, which included data collected while on randomized treatment prior to treatment discontinuation or step-up in maintenance therapy.
  • The results of a prespecified intention-to-treat analysis were also included in the BATURA publication and included all data, regardless of a step-up in maintenance therapy or treatment discontinuation.
  • Adverse events occurring in at least 2% of patients in any trial group were reported in the study. The most common adverse events in both treatment groups were upper respiratory tract infection, coronavirus disease 2019, and nasopharyngitis.
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You are about to leave RethinkingAsthmaRescue.com
Important Information for the Healthcare Professional

This study discusses some information about AIRSUPRA® (albuterol 90 mcg/budesonide 80 mcg) that is not contained in or consistent with the FDA-approved Prescribing Information.

AstraZeneca and Avillion executed a Co-Development Agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma: AstraZeneca manufactures and markets AIRSUPRA while Avillion was the clinical trial Sponsor and provided funding for MANDALA. Some authors may have a financial interest in either AIRSUPRA or AstraZeneca/Avillion and/or may have received compensation from AstraZeneca/Avillion in connection with this study or other engagements. AstraZeneca recommends use of AIRSUPRA only in accordance with its approved Prescribing Information. In connection with the discussions contained in the reprint, please note:

  • The study evaluated efficacy and safety for patients ≥4 years old. Only patients ≥12 years old received the approved dosage of AIRSUPRA (albuterol/budesonide 180/160 mcg). While patients <18 years old were included in MANDALA, AIRSUPRA is not approved for this age group.
  • The study assessed an albuterol/budesonide MDI 180/80 mcg as needed arm. This is not an approved dose.
  • This prespecified exploratory analysis from MANDALA evaluated asthma deterioration and the effect of as-needed albuterol/budesonide on progression from deterioration to a severe exacerbation.
  • A post hoc analysis evaluated albuterol/budesonide 180/160 mcg in patients ≥18 years old (FDA-approved population).
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IMPORTANT SAFETY INFORMATION

  • Contraindications: Hypersensitivity to albuterol, budesonide, or to any of the excipients

  • Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient continues to experience symptoms after using AIRSUPRA or requires more doses of AIRSUPRA than usual, it may be a marker of destabilization of asthma and requires evaluation of the patient and their treatment regimen

  • Paradoxical Bronchospasm: AIRSUPRA can produce paradoxical bronchospasm, which may be life threatening. Discontinue AIRSUPRA immediately and institute alternative therapy if paradoxical bronchospasm occurs. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister

  • Cardiovascular Effects: AIRSUPRA, like other drugs containing beta2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or other symptoms. If such effects occur, AIRSUPRA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. Therefore, AIRSUPRA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

  • Do Not Exceed Recommended Dose: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs

  • Hypersensitivity Reactions, Including Anaphylaxis: Can occur after administration of albuterol sulfate and budesonide, components of AIRSUPRA, as demonstrated by cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria. Discontinue AIRSUPRA if such reactions occur

  • Risk of Sympathomimetic Amines with Certain Coexisting Conditions: AIRSUPRA, like all therapies containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines

  • Hypokalemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. The decrease in serum potassium is usually transient, not requiring supplementation

  • Immunosuppression and Risk of Infections: Due to possible immunosuppression from the use of inhaled corticosteroids (ICS), potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients

  • Oropharyngeal Candidiasis: Has occurred in patients treated with ICS agents. Monitor patients periodically. Advise patients to rinse his/her mouth with water, if available, without swallowing after inhalation

  • Hypercorticism and Adrenal Suppression: May occur with very high doses in susceptible individuals. If such changes occur, consider appropriate therapy

  • Reduction in Bone Mineral Density: Decreases in bone mineral density have been observed with long-term administration of ICS. For patients at high risk for decreased bone mineral density, assess initially and periodically thereafter

  • Glaucoma and Cataracts: Have been reported following the long-term administration of ICS, including budesonide, a component of AIRSUPRA

  • Effects on Growth: Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of AIRSUPRA have not been established in pediatric patients, and AIRSUPRA is not indicated for use in this population

  • Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, and dysphonia

  • Drug Interactions: AIRSUPRA should be administered with caution to patients being treated with:

  • Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects)

  • Short-acting bronchodilators (concomitant use of additional beta-agonists with AIRSUPRA should be used judiciously to prevent beta-agonist overdose)

  • Beta-blockers (may block pulmonary effects of beta-agonists and produce severe bronchospasm)

  • Diuretics or non-potassium-sparing diuretics (may potentiate hypokalemia or ECG changes). Consider monitoring potassium levels

  • Digoxin (may decrease serum digoxin levels). Consider monitoring digoxin levels

  • Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants (Use AIRSUPRA with extreme caution; may potentiate effect of albuterol on the cardiovascular system)

  • Use AIRSUPRA with caution in patients with hepatic impairment, as budesonide systemic exposure may increase. Monitor patients with hepatic disease

INDICATION

AIRSUPRA is a combination of albuterol, a beta2-adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

This product information is intended for US healthcare professionals only.

IMPORTANT SAFETY INFORMATION