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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airsupra cohort | Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra |
| |
| Albuterol cohort | Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None (Observational study) | Other | Not applicable since it's an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion 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;
Exclusion Criteria:
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The study population will consist of a real-world adult population of asthma patients in a claims database using albuterol as rescue therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AstraZeneca | Wilmington | Delaware | 19803 | United States |
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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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. | 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. | 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. | 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. | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |