コントロールされていない患者の ICS + LABA 強度が中程度の喘息で 3 倍 (TRIMARAN)
CHF 5993 100/6/12.5 µg pMDI を比較する 52 週間、無作為化、二重盲検、多国籍、多施設、能動制御、2 アーム並列群試験/6 µg pMDI (エクストラファイン ベクロメタゾン ジプロピオン酸エステルとホルモテロール フマル酸エステルの固定配合剤) 中用量の吸入コルチコステロイドと長時間作用型 β2 アゴニストの併用でコントロールされていない喘息患者における
調査の概要
詳細な説明
This study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and following all other requirements of local laws.
From screening to the end of treatment, vital signs were recorded pre-dose at screening and pre- and postdose at all visits during the treatment period; physical examination was performed at all visits; concomitant medications and adverse events (AEs) were recorded, and asthma exacerbations were assessed at all visits; lung function tests were performed (pre-dose for forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) from screening to end of treatment visits, pre-dose for inspiratory capacity and vital capacity and postdose serial spirometry at all visits during the treatment period).
Patients completed the electronic diary from home twice daily from the time of screening until the end of treatment, to record asthma symptoms, treatment compliance, and use of rescue medication. Patients used the electronic peak flowmeter to record peak expiratory flow twice daily from home from the time of screening until the end of treatment.
Asthma Control Questionnaire© (ACQ)-7 was completed at screening and all visits during the treatment period. The EuroQuality of Life-5-Dimensional-3-Level questionnaire, and health economic and outcome assessments were competed at all visits during the treatment period.
Rescue medication (salbutamol 100 μg per inhalation) was permitted throughout the treatment period when absolutely needed; the maximum allowed dose was 8 inhalations/day (800 μg).
An independent Data Safety Monitoring Board was established to provide impartial safety evaluation and assurance for patients.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Rostock、ドイツ
- Chiesi Clinical Trial Site 276814
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
包含基準:
- -喘息の病歴が1年以上あり、40歳未満で診断された
- -ACQ-7（喘息コントロールアンケート）≥1.5の長時間作用型ベータ2アゴニスト（LABA）と組み合わせた中用量の吸入コルチコステロイド（ICS）のみの二重療法による制御されていない喘息
- 気管支拡張薬投与前の FEV1 < 予測正常値の 80%
- 陽性可逆性試験
- 前年に喘息の増悪が少なくとも 1 回記録されている
除外基準:
- 妊娠中または授乳中の女性
- 慢性閉塞性肺疾患（COPD）の診断
- -4週間前のスクリーニングで喘息の増悪または呼吸器感染症の患者
- 現在または元喫煙者 (>= 年に 10 パック)
- -4週間前のスクリーニングにおけるICS + LABAの組み合わせの用量、スケジュール、または製剤の変更
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
- 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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：CHF 5993 100/6/12.5 µg
CHF 5993 100/6/12.5 CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate GB=Glycopyrronium Bromide |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
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アクティブコンパレータ：CHF 1535 100/6 µg
CHF 1535 100/6 µg CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.
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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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1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
時間枠：Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in pre-dose FEV1 was analysed at Week 26 of treatment. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26.
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2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Asthma exacerbation (events): Moderate AND Severe. Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations). Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
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Week 0 (pre-treatment, baseline) to Week 52.
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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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20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
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Week 0 (pre-treatment, baseline) to Week 52.
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3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
時間枠：Week 0 (pre-treatment, baseline) and Week 26.
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Peak FEV1 was analysed within 3 hours post-dose. FEV1=Peak of forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) and Week 26.
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4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in the average morning PEF over the 26-Week treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26.
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5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
時間枠：The entire treatment period; up to Week 52.
|
Severe Asthma Exacerbation Rate over the 52-Week Treatment Period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
The entire treatment period; up to Week 52.
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6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in peak FEV1 (within 3 h post-dosing) at all clinical visits. Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value. |
Week 0 (pre-treatment, baseline) to Week 52.
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7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in pre-dose FEV1 at all clinical visits.
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Week 0 (pre-treatment, baseline) to Week 52.
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8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Results show the percentage of patients classified as FEV1 responders at both Week 26 and Week 52.
FEV1 response: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.
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Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2). Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose). |
Week 0 (pre-treatment, baseline) to Week 52.
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10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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ACQ-7 Questionnaire. Asthma Control Questionnaire-7 (ACQ-7) allows assessment of asthma control in individual patients. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function. |
Week 0 (pre-treatment, baseline) to Week 52.
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11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52
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Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above. An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data. Results represent the responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and Week 52. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52
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12a_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 52.
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12b_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a moderate or severe asthma exacerbation. Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period. |
Week 0 (pre-treatment, baseline) to Week 52.
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14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Data were analysed for the number of patients at risk of a severe asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of patients who had a severe asthma exacerbation over the 52 weeks treatment period. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
|
Moderate asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
|
Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
|
Moderate and severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of participants with moderate and severe asthma exacerbation. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Time to first moderate or severe asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of participants with moderate or severe asthma exacerbation. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Moderate asthma exacerbation rate over the 52-Week treatment period.
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Week 0 (pre-treatment, baseline) to Week 52.
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21a_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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21b_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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22a_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in the percentage of rescue medication-free days in each inter-visit period over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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22b_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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23a_Change From Baseline in the Average Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness.
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Week 0 (pre-treatment, baseline) to Week 52.
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23b_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average daily asthma symptom scores in each inter-visit period over the entire treatment. Data was collected daily through an electronic diary from screening to the end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness.
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Week 0 (pre-treatment, baseline) to Week 52.
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24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
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24b_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment. Data was collected through an electronic daily diary from screening to end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
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25a_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
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25b_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma control days in each inter-visit period. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Data was collected through an electronic daily diary from screening to the end of the study Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
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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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有害事象と副作用
時間枠：52週目まで
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52週目まで
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医療経済学の成果の収集
時間枠：0週から52週
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医療資源の総使用量と休業
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0週から52週
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協力者と研究者
捜査官
- 主任研究者：Christian Virchow, MD、Facharzt für Innere Medizin Rostock, Germany
出版物と役立つリンク
一般刊行物
- Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
- Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.
- Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
便利なリンク
- Study Record on EU Clinical Trials Register including results.
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB2-02; TRIGGER;
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN) ClinicalTrials.gov ID NCT02676076
- Time course of exacerbation reduction with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate to severe asthma: A post-hoc analysis of the TRIMARAN and TRIGGER Studies
- TRIple in Asthma hiGh strenGth vErsus Ics/ Laba hs and tiotRopium (TRIGGER)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CCD-05993AB1-03
- 2015-000716-18 (EudraCT番号)
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
Chiesi は、資格のある科学および医学研究者と共有し、正当な研究、患者レベルのデータ、研究レベルのデータ、臨床プロトコル、および完全な CSR を実施し、商業上の機密情報と患者を保護するという原則に一貫して臨床試験情報へのアクセスを提供することを約束します。プライバシー。 共有される患者レベルのデータは、個人を特定できる情報を保護するために匿名化されます。
Chiesi のアクセス基準と臨床データ共有の完全なプロセスは、Chiesi Group の Web サイトで入手できます。
IPD 共有アクセス基準
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。