Recruiting

Albuterol/Budesonide vs. ICS

Sponsor:

AstraZeneca

Code:

NCT07787117

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

None (observational study)

Study Details

Brief summary:

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.

Conditions

Asthma

Study ID

NCT07787117

Start date

Aug 3, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

8000 participants

Anticipated

Interventions and Outcome Measures

Arms

Airsupra cohort

Patients who switch from albuterol to Airsupra (albuterol/budesonide) as their rescue therapy.

Albuterol and low-dose ICS comparator cohort

Patients who add low-dose inhaled corticosteroid (ICS) to their ongoing albuterol rescue regimen.

Albuterol and LTRA comparator cohort

Patients who add leukotriene modifiers (LTRA) to their ongoing albuterol rescue regimen.

Interventions

None (observational study)

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.

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 and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Wilmington, Delaware, United States, 19803

More Information

Sponsor

AstraZeneca

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.