AsthmaGRANITENCT07141277
GRANITE: Airsupra Effectiveness in the Real World
An observational study of Asthma, run by AstraZeneca at 1 site in United States.
Trial summary
The GRANITE study aims to evaluate the effectiveness of Airsupra versus albuterol in reducing asthma exacerbation risk in a real-world US population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- None (Observational study)
- How many people
- 4,060 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 20 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- None (Observational study)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational study
Not applicable since it's an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Airsupra cohort | Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra Receives: Other: None (Observational study) | |
| Albuterol cohort | Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Time to first severe asthma exacerbation will be analyzed using the KM method and corresponding estimates of cumulative incidence over time will be plotted.
Measured: 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
Total exposure (days) for SCS, and SCS bursts rates will be described using summary statistics suitable for the distribution of the data.
Measured: 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)
Annualized exposure to ICS in μg/year fluticasone equivalents.
Measured: 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)
Annualized exposure to SCS in mg/year prednisone equivalent.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start9 Jul 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141277
- Sponsor's protocol ID
- D6930R00007
- Acronym
- GRANITE
- Status last verified
- May 2026
- First submitted
- 11 Jul 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07141277
- Acronym / sponsor ID
- GRANITE / D6930R00007
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,060 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GRANITE study aims to evaluate the effectiveness of Airsupra versus albuterol in reducing asthma exacerbation risk in a real-world US population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airsupra cohort | – | Other: None (Observational study)Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra |
| Albuterol cohort | – | Other: None (Observational study)Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Also: Observational studyNot applicable since it's an observational study. | Other | Airsupra cohort, Albuterol cohort |
Primary outcome
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.
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.
5 secondary outcomes
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.
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.
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol (time frame: Baseline period is 12 months prior to the index date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.