GRANITE: Airsupra Effectiveness in the Real World

NCT07141277 | Recruiting FDA Drug

• 1 other identifier: D6930R00007
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol

  Patient characteristics including demographics, clinical characteristics, asthma treatments, dosing, adherence to maintenance, asthma exacerbations, HCRU, and asthma severity defined per GINA will be described during the 12-month baseline period using descriptive statistics.

  Baseline period is 12 months prior to the index date

• Severe asthma exacerbations

  Number of patients with any severe asthma exacerbation and the rate of severe asthma exacerbation per person-year will be described during the follow-up period.

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

Secondary Outcomes (5)

• Median time to first exacerbation

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

• Total exposure for SCS and SCS bursts rates

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

• Annualized exposure to Inhaled Corticosteroid (ICS)

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

• Annualized exposure to Systemic Corticosteroids (SCS)

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

• Annualized exposure to ICS and SCS

  Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.

Study Arms (2)

Airsupra cohort

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

Other: None (Observational study)

Albuterol cohort

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

Other: None (Observational study)

Interventions

None (Observational study) OTHER

Not applicable since it's an observational study.

Also known as: Observational study

Airsupra cohort; Albuterol cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of a real-world adult population of asthma patients in a claims database using albuterol as rescue therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

AstraZeneca

Wilmington, Delaware, 19803, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Observation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 26, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)