CClinicalTrials.gg
CompletedNCT07141277GRANITEUpdated Jun 12, 2026

GRANITE: Airsupra Effectiveness in the Real World

An observational study in Asthma, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,060
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

Browse trials for

03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 4,060 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,060 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNone (Observational study)

    Not applicable since it's an observational study.

    Also known as: Observational study

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    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.

Secondary outcomes

  1. Median time to first exacerbation

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

    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.

  2. Total exposure for SCS and SCS bursts rates

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

    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.

  3. Annualized exposure to Inhaled Corticosteroid (ICS)

    Annualized exposure to ICS in μg/year fluticasone equivalents.

    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.

  4. Annualized exposure to Systemic Corticosteroids (SCS)

    Annualized exposure to SCS in mg/year prednisone equivalent.

    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.

  5. Annualized exposure to ICS and SCS

    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.

    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.

07

Study locations

1 site
  • AstraZeneca
    Wilmington, Delaware 19803, United States
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07141277
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 26, 2025
Start date
Jul 9, 2025
Primary completion
Mar 20, 2026
Completion
Mar 20, 2026
Last update
Jun 12, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion