RECRUITING

GRANITE: Airsupra Effectiveness in the Real World

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-07-09

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07141277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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	* 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

Inclusion Criteria

Exclusion 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:
* 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

* 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

AstraZeneca

Wilmington, Delaware, 19803

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-09

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-07-09

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Asthma