Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Airsupra cohort Patients who switch from albuterol to Airsupra (albuterol/budesonide) as their rescue therapy.
  • Other: 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.
    Other names:
    • 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)
    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.
    Other names:
    • Observational study
Albuterol and LTRA comparator cohort Patients who add leukotriene modifiers (LTRA) to their ongoing albuterol rescue regimen.
  • Other: 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.
    Other names:
    • Observational study

Recruiting Locations

Research Site
Wilmington, Delaware 19803

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.