Lung Function Study (DENALI)

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

DENALI

Study Design1,2

Phase III, randomized, double-blind, active-comparator and placebo-controlled lung function study conducted over 12 weeks that evaluated the efficacy and safety of albuterol/budesonide versus albuterol, budesonide, and placebo in patients with mild to moderate asthma.

Clinical Trials DENALI Study Design Graphic
Clinical Trials DENALI Study Design Graphic

Lung Function

  • Time to onset and duration of bronchodilation

Patient Population (N=989)

  • ≥12 years old

  • Mild to moderate asthma previously treated with:

  • SABA alone (as-needed), or

  • SABA (as-needed) + low-dose maintenance ICS

Inclusion/Exclusion Criteria

While patients 12 to 17 years old were included in DENALI, AIRSUPRA is not approved in this age group; therefore, efficacy results are only presented for adults ≥18 years of age. Since albuterol/budesonide 180/80 mcg is not an approved dose, this website will not include results for this arm of the study. AIRSUPRA is not indicated or approved for maintenance use.

Adult Efficacy Population (n=964)1

Clinical Trials Adult Efficacy Population Key Demographic Chart
Clinical Trials Adult Efficacy Population Key Demographic Chart

Lung Function Results

The profiles of albuterol/budesonide 180/160 mcg and albuterol were similar in terms of FEV1 response, including time to onset and duration of effect1

Lung Function Results Chart
Lung Function Results Chart1
Lung Function Results Chart2

Data shown are for patients ≥18 years old.1

*Time to onset was defined by the time from dose to first instance when a response (≥15% increase in FEV1 post-dose within 30 minutes on Day 1) was observed.3

†Duration was defined as the continual period in which the response (≥15% increase in FEV1, post-dose within 30 minutes on Day 1) was observed.3

‡Data shown only for patients who had a response to albuterol/budesonide 180/160 mcg or albuterol 180 mcg (51% and 43% of patients, respectively).1

*Time to onset was defined by the time from dose to first instance when a response (≥15% increase in FEV1 post-dose within 30 minutes on Day 1) was observed.3

†Duration was defined as the continual period in which the response (≥15% increase in FEV1, post-dose within 30 minutes on Day 1) was observed.3

‡Data shown only for patients who had a response to albuterol/budesonide 180/160 mcg or albuterol 180 mcg (51% and 43% of patients, respectively).1

Safety in the Overall DENALI Population

Summary of adverse reactions reported in ≥1% of patients1,4

Safety Summary Adverse Reactions Chart In DENALI
Safety Summary Adverse Reactions Chart In DENALI

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

Albuterol-budesonide pressurized metered dose inhaler in patients with mild-to-moderate asthma. Results of the DENALI double-blind randomized controlled trial

Chest, 2023

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

Specialist Perspective

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FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; QID, 4 times daily; SABA, short-acting β2-agonist.

References:

1. AIRSUPRA® (albuterol/budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Chipps BE, Israel E, Beasley R, et al. Albuterol-budesonide pressurized metered dose inhaler in patients with mild-to-moderate asthma: results of the DENALI double-blind randomized controlled trial. Chest. 2023;S0012-3692(23)00463-4. 3. Bond Avillion 2 Development LP. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03847896. 4. Data on File, REF-174347, AstraZeneca Pharmaceuticals LP.

DENALI: Select Inclusion and Exclusion Criteria1-3

Key Inclusion Criteria:

  • Patients with mild to moderate asthma

  • Receiving one of the following inhaled asthma medications with stable dosing for ≥30 days prior to screening:

  • - As-needed SABA, or

  • - Stable low-dose ICS plus as-needed SABA

  • Prebronchodilator FEV1 ≥50% to <85% predicted normal value (≥50% for patients aged 12 to 17 years)

  • Reversibility of FEV1 (≥15% increase vs baseline)

Key Exclusion Criteria:

  • COPD or other significant lung disease

  • SCS use in the 3 months prior to screening

  • Chronic SCS use (≥3 weeks) within 6 months prior to screening

  • Asthma-related hospitalization within 6 months prior to screening

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

COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; SABA, short-acting ß2-agonist; SCS, systemic corticosteroid.

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Important Information for the Healthcare Professional

This study discusses some information about AIRSUPRATM (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 DENALI. 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 included 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 DENALI, AIRSUPRA is not approved for this age group.
  • The study assessed an albuterol/budesonide MDI 180/80 mcg QID arm. This is not an approved dose. AIRSUPRA is not indicated or approved for maintenance use.
  • Adverse events occurring in at least 2% of patients in any trial group were reported in the study. The most common adverse events were nasopharyngitis, headache, and diarrhea.
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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