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

QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-Dose Inhaled Corticosteroids or Leukotriene Receptor Antagonists to Albuterol Among Adults With Asthma in the United States

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses past U.S. insurance records to compare asthma treatments in adults who used albuterol for quick relief. It looks at switching to albuterol/budesonide (Airsupra) versus adding a low-dose inhaled steroid or a medicine called an LTRA while keeping albuterol. The goal is to see which approach works better at reducing severe asthma attacks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have asthma and a prescription record for Airsupra, a low-dose inhaled steroid, or an LTRA since January 2023. An LTRA helps block substances that cause swelling in the airways.
  • Have an albuterol prescription record in the 12 months before starting the study treatment.
  • Be at least 18 years old when starting the study treatment.
  • Have insurance coverage without a break for at least 12 months before and 12 months after starting the study treatment.

Who can't join

  • Have an insurance record in the prior 12 months for certain long-term lung diseases or diseases causing inflammation throughout the body that are routinely treated with steroids acting throughout the body.
  • Have a prescription record for an inhaled steroid or another long-term asthma control medicine in the 12 months before or on the treatment start date. The low-dose inhaled steroid or LTRA used to enter its study group is allowed on that date.
  • Use steroid medicine taken by mouth as ongoing treatment in the 12 months before or on the treatment start date.
  • For the Airsupra group, have a prescription record for another short-acting quick-relief airway medicine on the same day Airsupra is started.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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