QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-dose ICS or LTRA to Albuterol (QUARTZ)
17 september 2026 bijgewerkt door: AstraZeneca
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
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.
Studie Overzicht
Studietype
Observationeel
Inschrijving (Geschat)
8000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studie Locaties
-
-
Delaware
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Wilmington, Delaware, Verenigde Staten, 19803
- Werving
- Research Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adults asthma patients
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Airsupra cohort
Patients who switch from albuterol to Airsupra (albuterol/budesonide) as their rescue therapy.
|
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.
Andere namen:
|
|
Albuterol and low-dose ICS comparator cohort
Patients who add low-dose inhaled corticosteroid (ICS) to their ongoing albuterol rescue regimen.
|
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.
Andere namen:
|
|
Albuterol and LTRA comparator cohort
Patients who add leukotriene modifiers (LTRA) to their ongoing albuterol rescue regimen.
|
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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
Tijdsspanne: 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.
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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
|
To describe and compare the time to first severe exacerbation among the Airsupra cohort and each comparator cohort.
|
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)
Tijdsspanne: 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
|
To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
|
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)
Tijdsspanne: 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
|
To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
|
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
Tijdsspanne: 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
|
To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
|
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
Tijdsspanne: 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
|
To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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.
|
To describe healthcare resource use (HCRU) among the Airsupra cohort and each comparator cohort.
|
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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 augustus 2026
Primaire voltooiing (Geschat)
30 september 2026
Studie voltooiing (Geschat)
30 september 2026
Studieregistratiedata
Eerst ingediend
3 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
21 augustus 2026
Eerst geplaatst (Werkelijk)
26 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 september 2026
Laatste update ingediend die voldeed aan QC-criteria
17 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D6930R00011
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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