QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-dose ICS or LTRA to Albuterol

AstraZeneca8,000 enrolled

Overview

The QUARTZ study is a retrospective observational cohort study using a prevalent new-user design and U.S. healthcare claims data to evaluate treatment effectiveness among patients with asthma. The study compares the real-world effectiveness of switching from albuterol-only rescue therapy to albuterol/budesonide versus adding low-dose inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA) while continuing albuterol. The primary objective is to assess the comparative effectiveness of these treatment strategies in reducing severe asthma exacerbations in routine clinical practice in the United States.

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Asthma

Interventions

None (observational study)OTHER

Not applicable since it's an observational study. There are three study cohorts: 1) Airsupra cohort 2)Albuterol and low-dose ICS comparator cohort and 3) Albuterol and LTRA comparator cohort.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Asthma patients with at least one prescription record (identified by NDC or Healthcare Common Procedure Coding System \[HCPCS\] codes) for Airsupra (Airsupra cohort), LD ICS or LTRA, (comparator cohort) since January 2023. * Patients with at least one prescription record (based on NDC or HCPCS codes) of albuterol within the 12 months prior to the first Airsupra or the controller medications prescription date * Patients aged ≥18 years on the index date * Patients with ≥12 months of continuous insurance enrolment prior and 12 months after 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 any of the chronic respiratory conditions or systemic inflammatory diseases routinely treated with systemic corticosteroids (SCS) * Patients with any prescription record for any ICS or other controller therapies (including SAMA, LABA, LAMA, LTRA, theophylline or biologics) within the 12 months prior to the and inclusive of index date (the index therapy defining cohort entry (LD ICS for the LD ICS cohort; LTRA for the LTRA cohort is permitted on the index date) * Patients with maintenance OCS use within the 12 months prior to and inclusive of the index date * Airsupra patients with a concomitant SABA prescription record on the index date

Outcomes

Primary Outcomes

Severe exacerbations during follow-up: annualized asthma exacerbation rates (AAER) by cohort, overall and by setting (IP, ED/urgent care, outpatient); plus absolute rates and rate ratios comparing Airsupra with each comparator cohort

To describe and compare the occurrence of severe exacerbations observed among the Airsupra cohort and each comparator cohort.

Time frame: Follow-up starts the day after index and ends at the earliest of death, data end, insurance disenrollment, loss to follow-up, or switch to the alternative rescue treatment, up to 36 months; add-on maintenance therapy does not censor follow-up.

Secondary Outcomes

Time to first severe exacerbation: KM curves, median time by arm (if estimable), and Cox PH HRs comparing Airsupra with each comparator. Also, the proportion with at least 1 severe exacerbation at 3, 6, 9, and 12 months after treatment initiation.

To describe and compare the time to first severe exacerbation among the Airsupra cohort and each comparator cohort.

Time frame: Follow-up period for each patient starts the day after the index date and ends at the earliest date of death, end of data, end of insurance enrollment, loss to follow up, or switch to the alternative rescue treatment up to 36 months

Cumulative inhaled corticosteroid exposure (beclomethasone equivalent µg/year)

To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

Cumulative systemic corticosteroid exposure (prednisone equivalent mg/year)

To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

Total SCS exposure days

To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

SCS burst rates

To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-dose ICS or LTRA to Albuterol

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts