A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD (PIONEER)
A 24-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF6001 DPI in Patients With COPD on a Background Therapy
調査の概要
詳細な説明
This is a phase II, randomized, double-blind, double-dummy, placebo and active controlled multinational, multicenter, dose ranging, 6-arm parallel-group study to identify the optimal dose of CHF6001, PDE4 inhibitor under development, with respect to lung functions and symptoms.
After a 2-wk run-in period under formoterol (Oxis Turbohaler®) and rescue salbutamol prn, patients will be randomized to one of the 6 treatment groups. After the randomization, patients will be assessed after 3, 6, 12, 18 and 24 weeks of treatment at clinic/hospital. A follow-up visit will be performed 12 days after the last visit.
During the study, patients will report daily symptoms with the EXACT-PRO/E-RS questionnaire, rescue/background medication use and compliance with the study medications. AEs, SAEs and COPD exacerbations will be monitored throughout the study. At randomization and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurement, 12-lead ECG. Symptoms and Health status will be assessed through validated questionnaires. Routine lab analysis and blood biomarkers will be done.
研究の種類
入学 (実際)
段階
- フェーズ2
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
受講資格のある性別
説明
Inclusion Criteria:
- COPD patients
- Non- childbearing potential or woman permanently sterilized or on one or more highly effective contraception
- Current/ex smokers (history > 10 pack years)
- Post bronchodilatator FEV1 >=30% and <=70% predicted normal value and FEV1/FVC ratio <0.7
- Documented history of at least 1 moderate or severe exacerbation in the 12 months prior to study entry
- Symptomatic patients (MMRC score ≥2 and a CAT score ≥10)
- Patients on daily maintenance therapy with an ICS/LABA .
Exclusion Criteria:
- Diagnosis of asthma or other respiratory disorders
- Maintenance bronchodilators therapy only (eg LABA alone)
- Maintenance triple therapy.
- Occurrence of a moderate or severe COPD exacerbation within 6 weeks prior to study entry or during the run-in period.
- Patients requiring long term oxygen therapy.
- Concomitant or recent pulmonary rehabilitation programme
- Known respiratory disorders other than COPD
- Lung cancer or a history of lung cancer, active or history of cancer with less than 5 years disease free survival time
- Hypersensitivity to β2-agonist, corticosteroids, PDE4 inhibitors or any of the excipients
- Depression, generalised anxiety disorder, suicidal ideation
- Any clinically significant cardiovascular disease (IM, CHF III/IV; AF not controlled by therapy, etc) within 1 year of study entry
- Any relevant clinically significant cardiovascular condition, clinically abnormal significant 12-lead ECG (QTcF>450 ms for male and >470 for female) or clinically significant laboratory abnormalities
- Serum potassium value ≤3.5 mEq/L or >5.5mEq/L and/or a fasting serum glucose value ≥140 mg/dL.
- History or symptoms of significant neurological disease
- Unstable concurrent disease: eg uncontrolled Thyroid disease or other endocrine diseases, gastrointestinal uncontrolled disease, uncontrolled immune diseases
- Renal impairment.
- Patients with abnormal alanine aminotransferase and/ or aspartate aminotransferase and/or bilirubin
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities and patients receiving treatment with any drug known to have a well defined potential for hepatotoxicity before Study entry
- Severely obese (BMI ≥35 kg/m2) or have experienced excessive weight loss recently
- History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
- Any recent participation to a clinical Study with other investigational drug
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 |
---|---|
実験的:CHF6001 DOSE1
DOSE1
|
Dose response: Test one of 4 different doses of CHF6001
他の名前:
|
実験的:CHF6001 DOSE2
DOSE2
|
Dose response: Test one of 4 different doses of CHF6001
他の名前:
|
実験的:CHF6001 DOSE3
DOSE3
|
Dose response: Test one of 4 different doses of CHF6001
他の名前:
|
実験的:CHF6001 DOSE4
DOSE4
|
Dose response: Test one of 4 different doses of CHF6001
他の名前:
|
プラセボコンパレーター:Matched placebo
placebo control
|
プラセボ対照
|
アクティブコンパレータ:Budesonide
Budesonide DPI 800µg
|
active control
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 from baseline in predose morning FEV1 at 12 weeks
時間枠:week 12
|
overall effect of CHF6001 on change from baseline in predose morning FEV1
|
week 12
|
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 predose morning FEV1 at other timepoints
時間枠:weeks 3, 6, 18, 24
|
Change from Baseline
|
weeks 3, 6, 18, 24
|
Change from baseline in pre-dose morning IC
時間枠:weeks 3, 6, 12, 18, 24
|
Change from Baseline for other lung function parameters
|
weeks 3, 6, 12, 18, 24
|
Change from baseline in pre-dose morning FVC
時間枠:weeks 3, 6, 12, 18, 24
|
Change from Baseline for other lung function parameters
|
weeks 3, 6, 12, 18, 24
|
Change from baseline in TDI focal score
時間枠:weeks 3, 6, 12, 18, 24
|
Change of TDI score
|
weeks 3, 6, 12, 18, 24
|
Change from baseline in SGRQ score
時間枠:weeks 3, 6, 12, 18, 24
|
Change of SGRQ score
|
weeks 3, 6, 12, 18, 24
|
Change from baseline in E-RS score
時間枠:weeks 3, 6, 12, 18, 24
|
Change of E-RSI score
|
weeks 3, 6, 12, 18, 24
|
COPD exacerbation rate over 24 weeks of treatment
時間枠:24 weeks
|
exacerbation rate
|
24 weeks
|
Time to first COPD exacerbation
時間枠:24 weeks
|
Time to first COPD exacerbation
|
24 weeks
|
協力者と研究者
捜査官
- 主任研究者:Dave Singh、Medicines Evaluation Unit, Manchester, UK
出版物と役立つリンク
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CCD-06001AA1-01
- 2015-005548-32 (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?
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
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プラセボの臨床試験
-
Palacky University完了
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
-
Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない