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NCT07141277 | RECRUITING | Asthma

GRANITE: Airsupra Effectiveness in the Real World
Sponsor:

AstraZeneca

Brief Summary:

The GRANITE study aims to evaluate the effectiveness of Airsupra versus albuterol in reducing asthma exacerbation risk in a real-world US population.

Condition or disease

Asthma

Intervention/treatment

None (Observational study)

Study Type : OBSERVATIONAL
Estimated Enrollment : 2000 participants
Official Title : 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
Actual Study Start Date : 2025-07-09
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2026-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
GRANITE: Airsupra Effectiveness in the Real World

Location Details

NCT07141277

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Locations

RECRUITING

United States, Delaware

AstraZeneca

Wilmington, Delaware, United States, 19803