GRANITE: Airsupra Effectiveness in the Real World

NCT ID: NCT07141277

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2026-03-31

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Airsupra cohort

Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra

None (Observational study)

Intervention Type: OTHER

Not applicable since it's an observational study.

Albuterol cohort

Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol

None (Observational study)

Intervention Type: OTHER

Not applicable since it's an observational study.

Interventions

None (Observational study)

Not applicable since it's an observational study.

Intervention Type: OTHER

Other Intervention Names

Observational study

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AstraZeneca

Wilmington, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

AstraZeneca Clinical Study Information Center

Role: CONTACT

information.center@astrazeneca.com

1-877-240-9479

Other Identifiers

D6930R00007

Identifier Type: -

Identifier Source: org_study_id