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Completed

NCT Number: NCT07141277

GRANITE: Airsupra Effectiveness in the Real World

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AstraZeneca

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None (Observational study)

Other

Not applicable since it's an observational study.

Other names: Observational study

Primary outcomes

  1. Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol

    Time frame: Baseline period is 12 months prior to the index date

    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.

  2. Severe asthma exacerbations

    Time frame: 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.

    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.

Secondary outcomes

  1. Median time to first exacerbation

    Time frame: 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.

    Time to first severe asthma exacerbation will be analyzed using the KM method and corresponding estimates of cumulative incidence over time will be plotted.

  2. Total exposure for SCS and SCS bursts rates

    Time frame: 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 (days) for SCS, and SCS bursts rates will be described using summary statistics suitable for the distribution of the data.

  3. Annualized exposure to Inhaled Corticosteroid (ICS)

    Time frame: 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 in μg/year fluticasone equivalents.

  4. Annualized exposure to Systemic Corticosteroids (SCS)

    Time frame: 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 SCS in mg/year prednisone equivalent.

  5. Annualized exposure to ICS and SCS

    Time frame: 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 total exposure to ICS and SCS the conversion factor of 5000 µg/day of inhaled budesonide to 10mg/day of oral prednisone will be used among Airsupra and the comparator albuterol cohort.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: GRANITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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