The GRANITE study aims to evaluate the effectiveness of Airsupra versus albuterol in reducing asthma exacerbation risk in a real-world US population.
Study Type
OBSERVATIONAL
Enrollment
2,000
Not applicable since it's an observational study.
AstraZeneca
Wilmington, Delaware, United States
RECRUITINGBaseline 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
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.
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.
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.
Annualized exposure to Inhaled Corticosteroid (ICS)
AstraZeneca Clinical Study Information Center
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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.
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.
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.