BACE Trial Substudy 1 - PROactive Substudy (PROactive)
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
調査の概要
詳細な説明
Physical activity is strongly reduced with exacerbations and failure to increase physical activity is associated with relapse. In addition, physical inactivity is known to be associated with cardiovascular and metabolic morbidity and is one of the strongest predictors of mortality in COPD. Apart from potential direct effects of the intervention on treatment failure and symptoms, positive effects on physical activity may offer considerable benefits in the long run.
Randomized patients that are willing to participate in the sub-study will be monitored for activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive medical intervention, differences in recovery of physical activity will be appreciated.
Patients will follow the standard protocol but will also wear the activity monitor for 7 days post discharge from hospital (at investigator discretion), at day 90 (end of treatment) and at day 270 (end of follow-up). This device is not only registering physical activity for 7 days but is also coupled to a standardized and patient-validated questionnaire on physical activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored) days.
Patient will have to give informed consent for the additional measures that are related to the activity sub-study. However, individual patients can still opt out for these tests (sub-study) and only participate in the medical intervention study (main study).
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Brussels Hoofdstedelijk Gewest
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Brussel、Brussels Hoofdstedelijk Gewest、ベルギー、1000
- St. Pieterziekenhuis
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Vlaanderen
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Antwerpen、Vlaanderen、ベルギー、2020
- ZNA Middelheim
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Bonheiden、Vlaanderen、ベルギー、2820
- Imelda Ziekenhuis
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Gent、Vlaanderen、ベルギー、9000
- UZ Gent
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Hasselt、Vlaanderen、ベルギー、3500
- Jessa Ziekenhuis
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Leuven、Vlaanderen、ベルギー、3000
- UZ Gasthuisberg
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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
受講資格のある性別
説明
Inclusion Criteria:
- Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
- Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
- Current hospitalization for potential infectious AECOPD treated with standard therapy
- History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
- ECG at admission
Exclusion Criteria:
- Mechanical or non-invasive ventilation at moment of randomization (D1)
- Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)
- History of life-threatening arrhythmias
- Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
- Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
- Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
- Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ < 0.5 mmol/L)
- Chronic systemic steroids (> 4 mg methylprednisolone /day for ≥ 2 months)
- Actual use of macrolides for at least 2 weeks
- Allergy to macrolides
- Active cancer treatment
- Life expectancy < 3 months
- Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
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：トリプル
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：Azithromycin
N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
1 日目から 3 日目まで：500 mg アジスロマイシンまたはプラセボ 1 日 1 回経口 4 日目から 90 日目まで：250 mg アジスロマイシンまたはプラセボ 2 日に 1 回経口
他の名前：
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
他の名前：
|
|
プラセボコンパレーター：Placebo
N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
他の名前：
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 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 |
|---|---|---|
|
Difference in Physical Activity (total amount of steps) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
時間枠：At discharge from hospital (0 months) and 3 months after start study drug intake
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Physical activity will be quantified as Total amount of steps
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At discharge from hospital (0 months) and 3 months after start study drug intake
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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 |
|---|---|---|
|
Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
時間枠：0 and 3 months
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Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 3 months
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0 and 3 months
|
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Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
時間枠：at baseline and 9 months
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Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 9 months
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at baseline and 9 months
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Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 9 months, or between 3 months and 9 months after randomisation
時間枠：baseline, 3 and 9 months
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Physical activity will be specified for:
|
baseline, 3 and 9 months
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Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
時間枠：At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be specified for:
|
At discharge from hospital (0 months) and 3 months after start study drug intake
|
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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Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
時間枠：at 0, 3 and 9 months
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at 0, 3 and 9 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始
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
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