ClinicalTrials.gg
CompletedNCT07787117QUARTZUpdated Oct 26, 2026

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

An observational study in Asthma, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by AstraZeneca · Observational

Updated Oct 26, 2026Now CompletedEnrollment updatedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,681
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.

Enrollment
9th of 110
8,681 · median 500
Started
2026
with 9 others
Observational
111 of 359
9 open now
Registered
357th of 359
by date

Among the 359 studies in Asthma by AstraZeneca, this one is the 9th largest by enrollment of the 110 observational ones that give a count, is one of 10 that started in 2026, is one of 111 observational ones, and was the 357th registered.

Asthma

4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.

Browse Asthma studies →

Open to participants now

19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 19 open studies →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Asthma

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04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults asthma patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,681 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNone (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.

    Also known as: Observational study

06

What researchers measure

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.

    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.

Secondary outcomes

  1. 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.

    To describe and compare the time to first severe exacerbation among the Airsupra cohort and each comparator cohort.

    Time frame: 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

  2. Cumulative inhaled corticosteroid exposure (beclomethasone equivalent µg/year)

    To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

    Time frame: 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

  3. Cumulative systemic corticosteroid exposure (prednisone equivalent mg/year)

    To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

    Time frame: 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

  4. Total SCS exposure days

    To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

    Time frame: 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

  5. SCS burst rates

    To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort

    Time frame: 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.

    To describe healthcare resource use (HCRU) among the Airsupra cohort and each comparator cohort.

    Time frame: 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.

07

Study locations

1 site
  • Research Site
    Wilmington, Delaware 19803, United States
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2026 to primary completion in Sep 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 26, 2026
StartActual
Aug 3, 2026
Primary completionActual
Sep 30, 2026
CompletionActual
Sep 30, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 26, 2026
Enrollment
8000 (estimated)→8681 (actual)
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Recruiting→Completed
    Enrollment 8000 (estimated)→8681 (actual)
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07787117
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Aug 3, 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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