GRANITE: Airsupra Effectiveness in the Real World. - GRANITE

Study identifier:D6930R00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

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.

Medical condition

asthma

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

2000

Study type

Observational

Age

18 Years - n/a

Date

Study Start Date: 31 Jul 2025

Estimated Primary Completion Date: 31 Mar 2026

Estimated Study Completion Date: 31 Mar 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jul 2025 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Airsupra cohort Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra	Other: None (Observational study) Not applicable since it's an observational study. Other Name: Observational study
Albuterol cohort Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol	Other: None (Observational study) Not applicable since it's an observational study. Other Name: Observational study

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]