QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-dose ICS or LTRA to Albuterol (QUARTZ)
2026年9月17日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
8000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
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Delaware
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Wilmington、Delaware、アメリカ、19803
- 募集
- Research Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults asthma patients
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Airsupra cohort
Patients who switch from albuterol to Airsupra (albuterol/budesonide) as their rescue therapy.
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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.
他の名前：
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Albuterol and low-dose ICS comparator cohort
Patients who add low-dose inhaled corticosteroid (ICS) to their ongoing albuterol rescue regimen.
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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.
他の名前：
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Albuterol and LTRA comparator cohort
Patients who add leukotriene modifiers (LTRA) to their ongoing albuterol rescue regimen.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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.
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To describe and compare the occurrence of severe exacerbations observed among the Airsupra cohort and each comparator cohort.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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
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To describe and compare the time to first severe exacerbation among the Airsupra cohort and each comparator cohort.
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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
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Cumulative inhaled corticosteroid exposure (beclomethasone equivalent µg/year)
時間枠：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
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To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
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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
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Cumulative systemic corticosteroid exposure (prednisone equivalent mg/year)
時間枠：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
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To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
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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
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Total SCS exposure days
時間枠：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
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To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
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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
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SCS burst rates
時間枠：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
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To describe exposure to corticosteroid treatments among the Airsupra cohort and each comparator cohort
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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.
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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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月3日
一次修了 (推定)
2026年9月30日
研究の完了 (推定)
2026年9月30日
試験登録日
最初に提出
2026年8月3日
QC基準を満たした最初の提出物
2026年8月21日
最初の投稿 (実際)
2026年8月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月17日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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