BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg]) (BETRI)
2026年7月30日 更新者：Chiesi Farmaceutici S.p.A.
A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS/LABA/LAMA (Beclometasone/Formoterol Fumarate/Glycopyrronium Bromide [87/5/9 pMDI { BD/FF/GB -100/6/12.5 μg} ]) vs Single Inhaler ICS/LABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200/6 pMDI { BD/FF - 200/6 μg} ]) in Asthma Subjects
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
調査の概要
状態
募集
条件
詳細な説明
This is a phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center.
The study aims to compare BDP/FF/GB pMDI 100/6/12.5
µg BID with BDP/FF pMDI 200/6 μg BID in adult participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.
研究の種類
介入
入学 (推定)
644
段階
- フェーズ 4
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：Clinical Trial INFO Chiesi Farmaceutici S.p.A.
- 電話番号：+39 0521 2791
- メール：clinicaltrials_info@chiesi.com
研究場所
-
-
-
Rousse、ブルガリア、7002
- 募集
- Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.
-
コンタクト：
- Nikolay Evgeniev Nikolaev
-
-
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
説明
Inclusion Criteria:
1 . Study participant's written informed consent obtained prior to any study related procedure.
2. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
4. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.
5. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
6. Women with childbearing potential (WOCBP) and with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.
7. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.
Note: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.
Exclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:
- Participation in another interventional clinical trial.
- Pregnant or breastfeeding women at the moment of enrolment.
- Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled/clinically significant diseases (according to investigator's judgement).
- Contraindication for LAMA use.
- Study participants on biological therapies for asthma.
- For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country/Region-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：BDP/FF/GB
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5
µg) - 2 inhalations bid
|
Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide BDP/FF/GB (100/6/12.5 µg per actuation) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.
他の名前：
|
|
アクティブコンパレータ：BDP/FF
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
|
Beclometasone dipropionate, formoterol fumarate (BDP/FF-200/6 µg) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.
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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in ACQ-5 score
時間枠：Baseline to Month 12 (Visit 7)
|
To demonstrate non inferiority of BDP/FF/GB-100/6/12.5 µg compared to BDP/FF-200/6 µg in terms of change in the Asthma Control Questionnaire-5 (ACQ-5) at Visit 7 (i.e. at Month 12) versus baseline. ACQ-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment). All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled). |
Baseline to Month 12 (Visit 7)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in ACQ-5 at all applicable visits.
時間枠：Baseline to Month 12 (Visit 7)
|
Change from baseline in ACQ-5 at all applicable visits.
Asthma Control Questionnaire-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment).
All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled).
|
Baseline to Month 12 (Visit 7)
|
|
Rate of severe asthma exacerbations
時間枠：Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.
|
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
|
Rate of moderate/severe asthma exacerbations
時間枠：Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months
|
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
|
Time to first severe asthma exacerbation.
時間枠：Month 12 treatment period
|
Time to first severe asthma exacerbation.
|
Month 12 treatment period
|
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Time to first moderate/severe asthma exacerbation.
時間枠：Month 12 treatment period
|
Time to first moderate/severe asthma exacerbation.
|
Month 12 treatment period
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Speed of change questionnaire at each applicable study visit.
時間枠：Month 12 treatment period
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Speed of change questionnaire at each applicable study visit.
|
Month 12 treatment period
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Eosinophils value
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
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Change from baseline in eosinophils value at each applicable study visit.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Chronic Airways Assessment Test (CAAT)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
CAAT questionnaire consists of 8 items scored from 0 to 5, with a total score ranging from 0 to 40; higher scores indicate worse health status.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Cardiovascular Event Rate
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event [AE] data collection)
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Asthma remission rate
時間枠：Month 6 (Visit 4), Month 12 (Visit 7)
|
Percentage of study participants with partial and complete asthma remission at 6 and 12 months.
|
Month 6 (Visit 4), Month 12 (Visit 7)
|
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Change in Spirometry parameters: FEV1
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1 (forced expiratory volume in 1 second), expressed as volume (L).
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Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Spirometry parameters: FVC
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FVC (forced vital capacity), expressed as volume (L).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEV1/FVC ratio
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1/FVC ratio, expressed as a percentage (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEF25-75
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEF25-75 (forced expiratory flow between 25% and 75% of FVC), expressed as flow (L/s).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Spirometry parameters: ratio of FEF25-75 to FVC
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: ratio of FEF25-75 to FVC.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEV1%
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1 as percentage of predicted normal values (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Spirometry parameters: FVC% of predicted normal
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FVC as percentage of predicted normal values (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Oscillometry parameters- R5 (Total airway resistance)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resistance at 5 Hz (R5), representing total airway resistance, expressed in kPa·L-¹·s.
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Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
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Change in Oscillometry parameters- R20 (Central airway resistance)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resistance at 20 Hz (R20), representing central airway resistance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Oscillometry parameters- R5-R20 (Peripheral airway resistance)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Difference between resistance at 5 Hz and 20 Hz (R5-R20), representing peripheral airway resistance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Oscillometry parameters-X5 (Reactance)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Reactance at 5 Hz (X5), reflecting distal airway reactance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Change in Oscillometry parameters-Fres (Resonant frequency)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resonant frequency (Fres), defined as the frequency at which reactance equals zero, expressed in Hz
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
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Change in Oscillometry parameters-AX (Area of reactance)
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Area of reactance (AX), representing the integrated low-frequency reactance, expressed in Hz·kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
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Oral systemic corticosteroids days
時間枠：Month 12 treatment period
|
Number of days with oral systemic corticosteroids
|
Month 12 treatment period
|
|
Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit.
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Test of Adherence to Inhalers (TAI) questionnaire change.
The TAI-10 score is automatically calculated on the electronic device by summing the individual item scores (1-10) ranging from 10-50, with higher score indicating better adherence.
The TAI 12-item total score is derived manually as sum of TAI-10 total score and items 11 and 12 scores.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in quality-of-life questionnaire: EQ-5D-5L
時間枠：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
EQ-5D-5L = EuroQol 5-Dimension 5-Level: index values range from <0 to 1 (higher values indicate better health), and EQ VAS scores range from 0 to 100 (higher scores indicate better self-rated health).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Oral systemic corticosteroids dose
時間枠：Month 12 treatment period
|
Dose of oral systemic corticosteroids (mg)
|
Month 12 treatment period
|
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。
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6月28日
一次修了 (推定)
2028年6月13日
研究の完了 (推定)
2028年6月13日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月19日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月31日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7月1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
- CLI-05993AB1-08
- 2025-524289-56-00 (Ctis)
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
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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