Asthma
Conditions
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.
Interventions
OTHERNone (Observational study)
Not applicable since it's an observational study.
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time to first severe asthma exacerbation will be analyzed using the KM method and corresponding estimates of cumulative incidence over time will be plotted. |
| 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. | Total exposure (days) for SCS, and SCS bursts rates will be described using summary statistics suitable for the distribution of the data. |
| 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 ICS in μg/year fluticasone equivalents. |
| 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 SCS in mg/year prednisone equivalent. |
| 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. | 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. |
Countries
United States
Outcome results
None listed