AIRSUPRA 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.
SUPERIOR EFFICACY ACROSS MULTIPLE ENDPOINTS
- Time to first severe exacerbation
- Annualized total SCS dose
- Safety
- Trial design
SUPERIOR REDUCTION IN EXACERBATION RISK VS ALBUTEROL1,2
Primary endpoint: Time to first severe exacerbation*
in exacerbation risk with AIRSUPRA vs albuterol2†
HR 0.54 (95% CI: 0.40, 0.72) P<0.001
*A severe exacerbation was defined by ≥1 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); an inpatient hospitalization due to asthma; or death.2
†Cox proportional hazards regression model adjusted for treatment, pretrial 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.1
HR, hazard ratio; ICS, inhaled corticosteroid; LTRA, leukotriene receptor antagonist; SABA, short-acting β2-agonist; SCS, systemic corticosteroid.
SUPERIOR DIFFERENCE IN ANNUALIZED SCS DOSE VS ALBUTEROL1,2
Key secondary endpoint: Annualized total systemic corticosteroid dose
in mean annualized SCS dose with AIRSUPRA vs albuterol1*
SAFETY PROFILE in patients with intermittent TO mild persistent ASTHMA2
Common adverse reactions reported
AIRSUPRA 180/160 mcg n=1209 n (%)
Albuterol 180 mcg n=1212 n (%)
Cough
30 (2.5)
29 (2.4)
Headache
15 (1.2)
13 (1.1)
Cough
Headache
AIRSUPRA 180/160 mcg n=1209 n (%)
30 (2.5)
15 (1.2)
Cough
Headache
Albuterol 180 mcg n=1212 n (%)
29 (2.4)
13 (1.1)
BATURA: AIRSUPRA VS ALBUTEROL AS RESCUE THERAPY IN INTERMITTENT TO MILD PERSISTENT ASTHMA3
Phase IIIb, randomized, double-blind, fully virtual, patient-centric, eventdriven exacerbation trial (≥12 weeks) in patients with asthma in the US ≥12 years of age3,4
BATURA: PATIENT POPULATION
Adult efficacy population (n=2353)4
Key Inclusion Criteria3
Diagnosis of asthma
Current 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 of ≥2 at baseline, indicating controlled disease†
Key Exclusion Criteria3
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, cromones, or medium-/highdose ICS as regular maintenance asthma therapy in the 3 months prior to enrollment
Use of SCS for the treatment of asthma or any other condition in the 6 weeks prior to enrollment
*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.3
†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, a score of 2-4 is not well controlled, and a score of 5-10 is very poorly controlled.3
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.
BATURA: PATIENT POPULATION
Adult efficacy population (n=2353)4
Key DEMOGRAPHICS4
Mean age: 43.5 years (range: 18+ years)
Gender:
- Male: 31.1%
- Female: 68.9%
Race:
- Caucasian: 70.4%
- Black/African American: 18.1%
- Other*: 11.5%
Ethnicity:
- Hispanic or Latino: 11.7%
- Non-Hispanic or Latino: 88.3%
Key CLINICAL PARAMETERS4
Median time since diagnosis (years): 25
Median time since last severe exacerbation (days): 147
AIRQ® score, mean (SD): 4.8
Baseline treatment and exacerbation history prior to screening:
- SABA alone
- No exacerbations in the 12 months prior to screening: 65.5%
- ≥1 exacerbation(s) in the 12 months prior to screening: 8.8%
- SABA plus low-dose ICS or LTRA
- No exacerbations in the 12 months prior to screening: 22.3%
- ≥1 exacerbation(s) in the 12 months prior to screening: 3.4%
PRE-TRIAL ASTHMA MEDICATION4
Patients were receiving SABA alone or with either low-dose ICS or LTRA maintenance therapy, if applicable
74%
SABA alone (n=1750)
26%
SABA plus low-dose ICS or LTRA (n=603)
*Included Asian, American Indian/Alaska Native, and Native Hawaiian/other Pacific Islander.
AIRQ, Asthma Impairment and Risk Questionnaire; ICS, inhaled corticosteroid; LTRA, leukotriene receptor antagonist; SABA, short-acting β2-agonist.
*Trial medication was administered via pMDI in 2 actuations of AIRSUPRA 90/80 mcg or albuterol 90 mcg, up to a maximum of 12 inhalations per day.3
†A severe exacerbation was defined by ≥1 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); an inpatient hospitalization due to asthma; or death.3
ICS, inhaled corticosteroid; LTRA, leukotriene receptor antagonist; pMDI, pressurized metered-dose inhaler; SCS, systemic corticosteroid.
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IMPORTANT SAFETY INFORMATION
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.
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Important Safety Information
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Important Safety Information
References:
1.LaForce C, Albers F, Danilewicz A, et al; BATURA Investigators. As-needed albuterol–budesonide in mild asthma. N Engl J Med. 2025;393(2):113-124. doi:10.1056/NEJMoa2504544
2.AIRSUPRA® (albuterol/budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.
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- 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
- 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
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