Airsupra compared with albuterol for asthma in everyday care

GRANITE: Airsupra Effectiveness in the Real World A Retrospective Prevalent New-user Cohort Study to Describe Characteristics and Compare Effectiveness of Airsupra vs Albuterol, in Patients With Asthma Requiring Use of Rescue Therapy in a Real-world Setting in the United States

This project tests whether Airsupra lowers the risk of asthma attacks more than albuterol for people with asthma using routine U.S. care.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (industry)
• Locations: 1 site (Wilmington, Delaware)
• Trial ID: NCT07141277 on ClinicalTrials.gov

What this trial studies

GRANITE is an observational, real-world comparison of patients prescribed Airsupra versus patients prescribed albuterol in the United States using prescription and claims data beginning January 2023. Eligible patients are identified by prescription records and HEDIS-based criteria indicating an asthma diagnosis in the prior 12 months. The main focus is on differences in asthma exacerbation risk between the two groups as captured in healthcare claims. No experimental interventions or randomized assignments are made; treatments are analyzed as they were prescribed in routine care.

Who should consider this trial

Good fit: Ideal candidates are people in the U.S. with at least one prescription record for Airsupra or albuterol since January 2023 and an asthma diagnosis (ICD-10 J45.xx) meeting HEDIS criteria in the prior 12 months.

Not a fit: People without U.S. prescription or claims records or who do not meet the specified HEDIS asthma criteria are unlikely to be eligible or to receive direct benefit from the analysis.

Why it matters

Potential benefit: If successful, the findings could help clinicians choose a rescue or maintenance option that better reduces asthma attacks in routine practice.

How similar studies have performed: Other claims-based, real-world comparisons of inhaled asthma therapies have sometimes shown meaningful differences in outcomes, but Airsupra-specific results are limited.

Eligibility criteria

Inclusion Criteria:

* Patients with at least one prescription record (based on NDC or healthcare common procedure coding system \[HCPCS\] codes) of Airsupra (for Airsupra arm) or albuterol (for selected albuterol comparator arm) since January 2023
* Patients with an asthma indication (indicated by an ICD-10-CM code J45.xx) within the 12 months prior to the index date identified by at least one of the following Health Plan Employer Data Information Set (HEDIS) criteria:

At least one IP claim with asthma as the principal admission diagnosis, At least one ED/urgent care claim with asthma as the principal diagnosis, At least four outpatient claims with asthma as one of the listed diagnoses AND at least two claims for any asthma medications (including any rescue or maintenance medications) within the 12 months prior to the index date, At least four prescriptions for any asthma medications within the 12 months prior to the index date;

* Patients with at least one prescription record (based on NDC or HCPCS codes) of albuterol within the 12 months prior to the index date
* Patients aged ≥18 years on the index date
* Patients with ≥12 months of continuous insurance enrolment prior to and post index date

Exclusion Criteria:

* Patients with at least one medical claim with an ICD-10 code within the 12 months prior to the index date for the following chronic respiratory conditions or other systematic inflammatory diseases routinely treated with SCS: COPD, cystic fibrosis, pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis, respiratory tract cancer, hypereosinophilic syndrome, Churg-Strauss syndrome, eosinophilic pneumonia, Wegener's granulomatosis, allergic bronchopulmonary aspergillosis, obesity hypoventilation syndrome, hyperventilation syndrome, alpha-1 antitrypsin deficiency, primary ciliary dyskinesia, vasculitis collagen vascular disease, systemic lupus erythematosus, scleroderma, rheumatoid arthritis, Sjogren's syndrome, psoriatic arthritis, or inflammatory bowel disease (ulcerative colitis and Crohn's disease)
* Patients with maintenance OCS use within the 12 months prior to the index date, defined as use of OCS covering minimum 50% (6 months) in days' supply
* Airsupra patients with a concomitant SABA prescription record on the index date

Where this trial is running

Wilmington, Delaware

• AstraZeneca — Wilmington, Delaware, United States (RECRUITING)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Asthma