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Recruiting NCT07141277

GRANITE: Airsupra Effectiveness in the Real World

Trial Parameters

Condition Asthma
Sponsor AstraZeneca
Study Type OBSERVATIONAL
Phase N/A
Enrollment 4,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-09
Completion 2026-06-30
Interventions
None (Observational study)

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.

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 o

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