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

Sponsor
AstraZeneca
Study ID
NCT07787117
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Aug 3, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
2,669 participants (estimated)

Arms

  • Arm: Airsupra cohort
    Patients who switch from albuterol to Airsupra (albuterol/budesonide) as their rescue therapy.
  • Arm: Albuterol and low-dose ICS comparator cohort
    Patients who add low-dose inhaled corticosteroid (ICS) to their ongoing albuterol rescue regimen.
  • Arm: Albuterol and LTRA comparator cohort
    Patients who add leukotriene modifiers (LTRA) to their ongoing albuterol rescue regimen.

Primary Outcome Measure

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 [ 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. ]

Central Contacts

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