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

NCT07787117 | Not Yet Recruiting FDA Drug

• 1 other identifier: D6930R00011
• Study Type: observational
• Target: 2,669
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (5)

• 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.

  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)

  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 systemic corticosteroid exposure (prednisone equivalent mg/year)

  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

• Total SCS exposure days

  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

• SCS burst rates

  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

Other Outcomes (1)

• Follow-up HCRU rates by arm: all-cause, asthma-related, and exacerbation-related use, including IP admissions, ED/urgent care, primary care, specialist outpatient visits, plus chest X-rays, oxygen treatment, and spirometry.

  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.

Study Arms (3)

Airsupra cohort

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

Other: None (observational study)

Albuterol and low-dose ICS comparator cohort

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

Other: None (observational study)

Albuterol and LTRA comparator cohort

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

Other: None (observational study)

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.

Also known as: Observational study

Airsupra cohort; Albuterol and LTRA comparator cohort; Albuterol and low-dose ICS comparator cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults asthma patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Asthma

Interventions

Observation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 26, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.