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慢性気道疾患、粘液レオロジーおよび増悪 (COPD-CARhE)

2026年9月21日 更新者：University Hospital, Montpellier

慢性気道疾患、粘液レオロジーおよび増悪：COPD患者の無作為対照試験

The main objective of this trial is to compare the exacerbation number over 12 months of follow-up between a group of patients with COPD treated according to standardized management (azithromycin prescribed in the event of severe sputum according to the CASA-Q score , standardized comparator arm) and a similar group in which azithromycin is prescribed based on mucus rheology (experimental arm) or CASA-Q.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The secondary objectives are to compare between the 2 arms:

  • exacerbation number according to their severity (observed throughout the duration of the study);
  • the evolution of the symptoms, the rheology of the sputum, and the pulmonary function (measurements repeated every three months);
  • medication consumption and adverse events (monitored throughout the duration of the study);
  • patient trajectories during follow-up;
  • the overall clinical improvement at the end of the study and the evolution of the quality of life (measurements repeated every 3 months);
  • the change in biomarkers of interest (baseline versus end of study).

研究の種類

介入

入学 (推定)

72

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

研究連絡先のバックアップ

研究場所

  • フランス
      • Bordeaux、フランス
        • 募集
        • University Hospitals of Bordeaux
        • 主任研究者：
          • Maéva Zysman, MD, PhD
      • Montpellier、フランス、34925
        • 募集
        • University Hospitals of Montpellier
        • 主任研究者：
          • Jérémy Charriot, MD
        • 副調査官：
          • Arnaud Bourdin, MD, PhD
        • 副調査官：
          • Anne-Sophie Gamez, MD
        • 副調査官：
          • Jean Romain, MD
      • Toulouse、フランス
        • 募集
        • University Hospitals of Toulouse
        • 主任研究者：
          • Laurent Guilleminault, MD
        • 副調査官：
          • Alain Didier, MD, PhD
        • 副調査官：
          • Danielle Brouquieres, MD
        • 副調査官：
          • Nicolas Guibert, MD
        • 副調査官：
          • Sandrine Pontier Marchandise, MD

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

40年～85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjets between 40 - 85 years (included)
  • Written and signed informed consent form
  • Subjects must be able to attend all planned visits and comply with all test procedures
  • Beneficiary of or affiliated with the French social security system
  • Man or woman with chronic obstructive pulmonary disease for at least 1 year defined according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and validated by the clinical investigator
  • Optimal treatment according to GOLD class severity C or D recommendations
  • >=3 exacerbation (regardless of severity: mild-moderate-severe) or ≥ 1 severe exacerbations (requiring hospitalization) in the past 12 months
  • Spontaneous or induced sputum production
  • Electrocardiogram: corrected distance between Q and T waves (QTC) <450 ms in men, QTC <470 ms in women
  • Normal audiogram for age or absence of contraindication to azithromycin for long course according to Oto-Rhino-Laryngological specialist opinion

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Patients who are prisoners or under other forms of judicial protection
  • Patients under any form of guardianship
  • Participation in another interventional protocol, (current or during the month preceding inclusion)
  • Received azithromycin in the past 3 months
  • Patient whose primary diagnosis is bronchial dilation based on CT scan documentation
  • Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used
  • Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)
  • Other respiratory diseases or associated lung infections
  • Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion)
  • Renal impairment with creatinine clearance < 40 mL/min
  • Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation
  • Patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary disease) due to the presence of lactose in the specialty Zithromax.

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：トリプル

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：Azithromycin according to symptoms

Patients randomized to this arm will be prescribed azithromycin in function of their symptoms.
薬：Azithropycin according to symptoms

Patients randomized to the "standardized comparator arm" will benefit from the standard treatment for COPD, including with regard to the prescription of azithromycin in case of severe sputum complaints (here defined by a CASA-Q sputum symptoms score <70 to homogenize practices between centers).

CASA-Q will be evaluated every 3 months.

  • If the patient has a sputum symptoms score <70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score <70.
  • If the patient has a sputum symptoms score> 70, management is not changed.
実験的：Azithromycin according to rheology

Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.
薬：Azithromycin according to rheology or symptoms

Treatment according to standard COPD management, except for the prescription of azithromycin, which will be prescribed in function of mucus rheology or as a function of sputum complaints (here defined by a CASA-Q sputum symptoms score <70).

The rheology of mucus will be quantified every 3 months.

  • If the patient has spontaneous or induced sputum, and this sputum has a critical constraint (tau-C) > 39, a prescription for 3 months of azithromycin treatment will be initiated. This prescription may be renewed every 3 months during the 12 months of follow-up planned in this study.
  • If the patient has a sputum symptoms score <70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score <70.
  • If the patient has a sputum symptoms score> 70, management is not changed.

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
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
時間枠：12 months

An exacerbation is defined according to French recommendations as an "acute event characterized by worsening of respiratory symptoms (notably cough, sputum and dyspnea) beyond [normal] daily variation and leading to a modification of treatment: either a simple increase in bronchodilators (in this case, a duration greater than 24 hours is required to define an exacerbation) or the addition of another treatment (antibiotic therapy and / or oral corticosteroid therapy)."
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
レオロジー: 粘液の弾性率 (G ')
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
レオロジー: 粘液の弾性率 (G ')
時間枠：3ヶ月
3ヶ月
レオロジー: 粘液の弾性率 (G ')
時間枠：6ヵ月
6ヵ月
レオロジー: 粘液の弾性率 (G ')
時間枠：9ヶ月
9ヶ月
レオロジー: 粘液の弾性率 (G ')
時間枠：12ヶ月
12ヶ月
レオロジー: 粘性モジュール (G '')
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
レオロジー: 粘性モジュール (G '')
時間枠：3ヶ月
3ヶ月
レオロジー: 粘性モジュール (G '')
時間枠：6ヵ月
6ヵ月
レオロジー: 粘性モジュール (G '')
時間枠：9ヶ月
9ヶ月
レオロジー: 粘性モジュール (G '')
時間枠：12ヶ月
12ヶ月
レオロジー: 比率 G '' / G '
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
レオロジー: 比率 G '' / G '
時間枠：3ヶ月
3ヶ月
レオロジー: 比率 G '' / G '
時間枠：6ヵ月
6ヵ月
レオロジー: 比率 G '' / G '
時間枠：9ヶ月
9ヶ月
レオロジー: 比率 G '' / G '
時間枠：12ヶ月
12ヶ月
レオロジー: 重要な制約 (tau-C)。
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
レオロジー: 重要な制約 (tau-C)。
時間枠：3ヶ月
3ヶ月
レオロジー: 重要な制約 (tau-C)。
時間枠：6ヵ月
6ヵ月
レオロジー: 重要な制約 (tau-C)。
時間枠：9ヶ月
9ヶ月
レオロジー: 重要な制約 (tau-C)。
時間枠：12ヶ月
12ヶ月
スパイロメトリー: 1 分間の努力呼気量 (FEV1)
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
スパイロメトリー: 1 分間の努力呼気量 (FEV1)
時間枠：3ヶ月
3ヶ月
スパイロメトリー: 1 分間の努力呼気量 (FEV1)
時間枠：6ヵ月
6ヵ月
スパイロメトリー: 1 分間の努力呼気量 (FEV1)
時間枠：9ヶ月
9ヶ月
スパイロメトリー: 1 分間の努力呼気量 (FEV1)
時間枠：12ヶ月
12ヶ月
スパイロメトリー: 強制肺活量 (FVC)
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
スパイロメトリー: 強制肺活量 (FVC)
時間枠：3ヶ月
3ヶ月
スパイロメトリー: 強制肺活量 (FVC)
時間枠：6ヵ月
6ヵ月
スパイロメトリー: 強制肺活量 (FVC)
時間枠：9ヶ月
9ヶ月
スパイロメトリー: 強制肺活量 (FVC)
時間枠：12ヶ月
12ヶ月
スパイロメトリー: FEV1/FVC
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
スパイロメトリー: FEV1/FVC
時間枠：3ヶ月
3ヶ月
スパイロメトリー: FEV1/FVC
時間枠：6ヵ月
6ヵ月
スパイロメトリー: FEV1/FVC
時間枠：9ヶ月
9ヶ月
スパイロメトリー: FEV1/FVC
時間枠：12ヶ月
12ヶ月
肺容量のプレチスモグラフィー: 残気量 (RV)
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
肺容量のプレチスモグラフィー: 残気量 (RV)
時間枠：3ヶ月
3ヶ月
肺容量のプレチスモグラフィー: 残気量 (RV)
時間枠：6ヵ月
6ヵ月
肺容量のプレチスモグラフィー: 残気量 (RV)
時間枠：9ヶ月
9ヶ月
肺容量のプレチスモグラフィー: 残気量 (RV)
時間枠：12ヶ月
12ヶ月
肺容量のプレチスモグラフィー: 機能的残気量 (FRC)
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
肺容量のプレチスモグラフィー: 機能的残気量 (FRC)
時間枠：3ヶ月
3ヶ月
肺容量のプレチスモグラフィー: 機能的残気量 (FRC)
時間枠：6ヵ月
6ヵ月
肺容量のプレチスモグラフィー: 機能的残気量 (FRC)
時間枠：9ヶ月
9ヶ月
肺容量のプレチスモグラフィー: 機能的残気量 (FRC)
時間枠：12ヶ月
12ヶ月
肺容量のプレチスモグラフィー: 総肺気量 (TLC)
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
肺容量のプレチスモグラフィー: 総肺気量 (TLC)
時間枠：3ヶ月
3ヶ月
肺容量のプレチスモグラフィー: 総肺気量 (TLC)
時間枠：6ヵ月
6ヵ月
肺容量のプレチスモグラフィー: 総肺気量 (TLC)
時間枠：9ヶ月
9ヶ月
肺容量のプレチスモグラフィー: 総肺気量 (TLC)
時間枠：12ヶ月
12ヶ月
肺容量のプレチスモグラフィー: RV/TLC
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
肺容量のプレチスモグラフィー: RV/TLC
時間枠：3ヶ月
3ヶ月
肺容量のプレチスモグラフィー: RV/TLC
時間枠：6ヵ月
6ヵ月
肺容量のプレチスモグラフィー: RV/TLC
時間枠：9ヶ月
9ヶ月
肺容量のプレチスモグラフィー: RV/TLC
時間枠：12ヶ月
12ヶ月
研究中の薬物消費。
時間枠：12ヶ月
12ヶ月
有害事象の数は、研究を通して記録されます。
時間枠：12ヶ月
12ヶ月
Serum Club 細胞分泌タンパク質
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
Serum Club 細胞分泌タンパク質
時間枠：12ヶ月
12ヶ月
喀痰細菌学
時間枠：ベースライン (0 日目)
ベースライン (0 日目)
喀痰細菌学
時間枠：12ヶ月
12ヶ月
The number of mild exacerbations throughout follow-up
時間枠：12 months

A mild exacerbation does not require new additional medicine.
12 months
The number of moderate exacerbations throughout follow-up
時間枠：12 months

Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization).
12 months
The number of severe exacerbations throughout follow-up
時間枠：12 months

Severe exacerbations require hospitalization.
12 months
COPD Assessment Test (CAT)
時間枠：Baseline (Day 0)

Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Baseline (Day 0)
COPD Assessment Test (CAT)
時間枠：3 months

Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
3 months
COPD Assessment Test (CAT)
時間枠：6 months

Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
6 months
COPD Assessment Test (CAT)
時間枠：9 months

Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
9 months
COPD Assessment Test (CAT)
時間枠：12 months

Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
12 months
Sino Nasal Outcome Test 22
時間枠：Baseline (Day 0)

The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
Baseline (Day 0)
Sino Nasal Outcome Test 22
時間枠：3 months

The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
3 months
Sino Nasal Outcome Test 22
時間枠：6 months

The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
6 months
Sino Nasal Outcome Test 22
時間枠：9 months

The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
9 months
Sino Nasal Outcome Test 22
時間枠：12 months

The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
12 months
Cough and sputum assessment questionnaire (CASA-Q)
時間枠：Baseline (Day 0)

The four domains of the CASA-Q (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings.
Baseline (Day 0)
Cough and sputum assessment questionnaire (CASA-Q)
時間枠：3 months

The four domains of the CASA-Q (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings.
3 months
Cough and sputum assessment questionnaire (CASA-Q)
時間枠：6 months

The four domains of the CASA-Q (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings.
6 months
Cough and sputum assessment questionnaire (CASA-Q)
時間枠：9 months

The four domains of the CASA-Q (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings.
9 months
Cough and sputum assessment questionnaire (CASA-Q)
時間枠：12 months

The four domains of the CASA-Q (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings.
12 months
Visual analogue scale for dyspnea
時間枠：Baseline (Day 0)

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Baseline (Day 0)
Visual analogue scale for dyspnea
時間枠：3 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
3 months
Visual analogue scale for dyspnea
時間枠：6 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
6 months
Visual analogue scale for dyspnea
時間枠：9 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
9 months
Visual analogue scale for dyspnea
時間枠：12 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
12 months
Visual analogue scale for coughing
時間枠：Baseline (Day 0)

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Baseline (Day 0)
Visual analogue scale for coughing
時間枠：3 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
3 months
Visual analogue scale for coughing
時間枠：6 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
6 months
Visual analogue scale for coughing
時間枠：9 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
9 months
Visual analogue scale for coughing
時間枠：12 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
12 months
Visual analogue scale for sputum production
時間枠：Baseline (Day 0)

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Baseline (Day 0)
Visual analogue scale for sputum production
時間枠：3 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
3 months
Visual analogue scale for sputum production
時間枠：6 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
6 months
Visual analogue scale for sputum production
時間枠：9 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
9 months
Visual analogue scale for sputum production
時間枠：12 months

A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
12 months
Episodes of exacerbation throughout the study
時間枠：12 months

For each exacerbation, the beginning and end dates will be recorded.
12 months
Episodes of hospitalization throughout the study
時間枠：12 months

For each hospitalization, the beginning and end dates will be recorded.
12 months
Clinical improvement
時間枠：12 months

Clinical improvement is scored via a point system from 0 to 3 at the end of the study. The points are added-up as follows:

  • 1 point: no more than one exacerbation without hospitalization during the 52 weeks of follow-up;
  • 1 point: gain > 100mL in pre-bronchodilator FEV1 at the 52nd week compared to the baseline state;
  • 1 point: variation of the CAT score during the 52 weeks of observation > 2.
12 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
時間枠：Baseline (day 0)

The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Baseline (day 0)
Medical outcomes study 36-Item Short Form Survey (SF-36)
時間枠：3 months

The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
3 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
時間枠：6 months

The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
6 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
時間枠：9 months

The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
9 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
時間枠：12 months

The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
12 months
EQ-5D-5L
時間枠：Baseline (day 0)

In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Baseline (day 0)
EQ-5D-5L
時間枠：3 months

In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
3 months
EQ-5D-5L
時間枠：6 months

In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
6 months
EQ-5D-5L
時間枠：9 months

In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
9 months
EQ-5D-5L
時間枠：12 months

In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
12 months
St-George's Respiratory Questionnaire
時間枠：Baseline (day 0)

Scores range from 0 to 100, with higher scores indicating more limitations.
Baseline (day 0)
St-George's Respiratory Questionnaire
時間枠：3 months

Scores range from 0 to 100, with higher scores indicating more limitations.
3 months
St-George's Respiratory Questionnaire
時間枠：6 months

Scores range from 0 to 100, with higher scores indicating more limitations.
6 months
St-George's Respiratory Questionnaire
時間枠：9 months

Scores range from 0 to 100, with higher scores indicating more limitations.
9 months
St-George's Respiratory Questionnaire
時間枠：12 months

Scores range from 0 to 100, with higher scores indicating more limitations.
12 months
Blood cell differential: neutrophil levels
時間枠：Baseline (day 0)

A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Baseline (day 0)
Blood cell differential: eosinophil levels
時間枠：Baseline (day 0)

A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Baseline (day 0)
Blood cell differential: neutrophil levels
時間枠：12 months

A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
12 months
Blood cell differential: eosinophil levels
時間枠：12 months

A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
12 months

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。

スポンサー

University Hospital, Montpellier

協力者

Rheonova

捜査官

  • スタディディレクター：Jérémy Charriot, MD、University Hospital, Montpellier

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)

2023年2月3日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2020年4月2日

QC基準を満たした最初の提出物

2020年4月5日

最初の投稿 (実際)

2020年4月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9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

  • RECHMPL19_0074

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

The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).

IPD 共有時間枠

As close to "real time" as possible, the following supporting information will be made public:

  • Study Protocol (to be published in an appropriate journal).
  • Statistical Analysis Plan
  • Participant Information materials
  • Analytic code

These will be posted and registered on osf.io and/or clinicaltrials.gov (if not published).

Datasets can be requested after the publication process has been completed.

IPD 共有アクセス基準

The conditions under which members of the public will be granted access to datasets are:

  • The data will be used/examined in a not-for-profit manner;
  • The data will not be used in an attempt to identify a participant or group of participants;
  • The user does not work for a private insurance company;
  • The data will not be used in support of any kind of private insurance policy or health penalties;
  • The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;
  • The user will state why they wish to access the data.
  • The appropriate CNIL approval has been obtained by the user.

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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