Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) (BENTEN)
BENTEN Study: Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI): a Prospective, Multi-centers, Observational Study
This is a single arm, prospective non-interventional study with primary data collection in patients initiated BGF MDI treatment as part of routine clinical care. In this study, 200 patients will be enrolled from approximately 20 sites mainly in general hospitals with respiratory/allergy/asthma specialists in Japan.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：Yoichi Tamai
- 電話番号：070-2453-4913
- メール：yoichi.tamai@astrazeneca.com
研究連絡先のバックアップ
- 名前：Hitomi Uchimura
- 電話番号：06-4802-3600
- メール：hitomi.uchimura@astrazeneca.com
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population will be composed of 200 patients with asthma who are newly initiated BGF MDI treatment and who can regularly visit the study site in Japan.
説明
Inclusion Criteria:
- Patients aged >=18 years at enrollment
- Patients diagnosed with asthma with an ACQ -5 score ≥1.5 at enrollment
- Patients who are judged to newly initiate BGF MDI (320/28.8/9.6 ug) treatment as per the investigator's decision and are able to initiate inhalation on the same day as the prescription or, if they have already used another inhaled medication on that day, on the following day.
- Patients who are capable to fill PRO physically and mentally as judged by investigator
- Patients who are assessed as able to visit the study site during the 8-week follow-up period
- Patients who provide written informed consent
Exclusion Criteria:
- Patients who have been treated with ICS/LABA/LAMA within 6 months before enrollment
- Patients who have participated in any interventional studies within 1 year before enrollment
- Patients who have history of asthma exacerbation within 4 weeks before enrollment
- Patients who have history of respiratory infection within 4 weeks before enrollment
- Patients who are prescribed systemic corticosteroids within 4 weeks before enrollment
- Patients who have been treated with any biologic therapy for asthma (e.g., anti-IgE, anti-IL-5/IL-5R, anti-IL-4R, anti-TSLP) within 1 year before enrollment
- Patients who are pregnant, lactating or intending to become pregnant during the study period
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Patients with asthma newly initiated on BGF MDI
The study population will include approximately 200 adult patients with asthma in Japan who are newly initiated BGF MDI treatment, have an ACQ-5 score ≥1.5 at enrollment. |
Initiation of BGF MDI treatment in routine clinical practice.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
時間枠：at Week 8
|
To evaluate the change in asthma control at 8 weeks from baseline in patients with asthma initiated on BGF MDI, as measured by ACQ-5. |
at Week 8
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment
時間枠：at week 8 from baseline
|
To evaluate changes in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment (defined in 3.5) |
at week 8 from baseline
|
|
Changes in asthma control measured by ACQ-5
時間枠：at week 2 and 4 from baseline
|
To evaluate changes in asthma control measured by ACQ-5 at 2 and 4 weeks from baseline in the asthma patients initiated with BGF MDI |
at week 2 and 4 from baseline
|
|
Changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ)
時間枠：at weeks 2, 4 and 8 from baseline
|
To evaluate changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4 and 8 from baseline
|
|
Proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5
時間枠：at weeks 2, 4 and 8 from baseline
|
To evaluate proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5 at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4 and 8 from baseline
|
|
Proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score
時間枠：at weeks 2, 4, 8 from baseline
|
To evaluate proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4, 8 from baseline
|
|
Onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ)
時間枠：5 and 30 minutes after the first administration
|
To evaluate the onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ) at 5 and 30 minutes after the first administration |
5 and 30 minutes after the first administration
|
|
Changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q)
時間枠：2, 4 and 8 weeks from baseline
|
To evaluate changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
2, 4 and 8 weeks from baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- D5980R00145
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?
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 rerefer 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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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