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Maladie chronique des voies respiratoires, rhéologie du mucus et exacerbations (COPD-CARhE)

21 septembre 2026 mis à jour par: University Hospital, Montpellier

Maladie chronique des voies respiratoires, rhéologie du mucus et exacerbations : un essai contrôlé randomisé de patients atteints de MPOC

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

72

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
      • Bordeaux, France
        • Recrutement
        • University Hospitals of Bordeaux
        • Chercheur principal:
          • Maéva Zysman, MD, PhD
      • Montpellier, France, 34925
        • Recrutement
        • University Hospitals of Montpellier
        • Chercheur principal:
          • Jérémy Charriot, MD
        • Sous-enquêteur:
          • Arnaud Bourdin, MD, PhD
        • Sous-enquêteur:
          • Anne-Sophie Gamez, MD
        • Sous-enquêteur:
          • Jean Romain, MD
      • Toulouse, France
        • Recrutement
        • University Hospitals of Toulouse
        • Chercheur principal:
          • Laurent Guilleminault, MD
        • Sous-enquêteur:
          • Alain Didier, MD, PhD
        • Sous-enquêteur:
          • Danielle Brouquieres, MD
        • Sous-enquêteur:
          • Nicolas Guibert, MD
        • Sous-enquêteur:
          • Sandrine Pontier Marchandise, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Azithromycin according to symptoms

Patients randomized to this arm will be prescribed azithromycin in function of their symptoms.
Médicament: 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.
Expérimental: Azithromycin according to rheology

Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rhéologie : module d'élasticité du mucus (G')
Délai: Base de référence (Jour 0)
Base de référence (Jour 0)
Rhéologie : module d'élasticité du mucus (G')
Délai: 3 mois
3 mois
Rhéologie : module d'élasticité du mucus (G')
Délai: 6 mois
6 mois
Rhéologie : module d'élasticité du mucus (G')
Délai: 9 mois
9 mois
Rhéologie : module d'élasticité du mucus (G')
Délai: 12 mois
12 mois
Rhéologie : le module visqueux (G'')
Délai: Base de référence (Jour 0)
Base de référence (Jour 0)
Rhéologie : le module visqueux (G'')
Délai: 3 mois
3 mois
Rhéologie : le module visqueux (G'')
Délai: 6 mois
6 mois
Rhéologie : le module visqueux (G'')
Délai: 9 mois
9 mois
Rhéologie : le module visqueux (G'')
Délai: 12 mois
12 mois
Rhéologie : Le rapport G'' / G'
Délai: Base de référence (Jour 0)
Base de référence (Jour 0)
Rhéologie : Le rapport G'' / G'
Délai: 3 mois
3 mois
Rhéologie : Le rapport G'' / G'
Délai: 6 mois
6 mois
Rhéologie : Le rapport G'' / G'
Délai: 9 mois
9 mois
Rhéologie : Le rapport G'' / G'
Délai: 12 mois
12 mois
Rhéologie : la contrainte critique (tau-C).
Délai: Base de référence (Jour 0)
Base de référence (Jour 0)
Rhéologie : la contrainte critique (tau-C).
Délai: 3 mois
3 mois
Rhéologie : la contrainte critique (tau-C).
Délai: 6 mois
6 mois
Rhéologie : la contrainte critique (tau-C).
Délai: 9 mois
9 mois
Rhéologie : la contrainte critique (tau-C).
Délai: 12 mois
12 mois
Spirométrie : volume expiratoire forcé en 1 minute (FEV1)
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Spirométrie : volume expiratoire forcé en 1 minute (FEV1)
Délai: 3 mois
3 mois
Spirométrie : volume expiratoire forcé en 1 minute (FEV1)
Délai: 6 mois
6 mois
Spirométrie : volume expiratoire forcé en 1 minute (FEV1)
Délai: 9 mois
9 mois
Spirométrie : volume expiratoire forcé en 1 minute (FEV1)
Délai: 12 mois
12 mois
Spirométrie : capacité vitale forcée (CVF)
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Spirométrie : capacité vitale forcée (CVF)
Délai: 3 mois
3 mois
Spirométrie : capacité vitale forcée (CVF)
Délai: 6 mois
6 mois
Spirométrie : capacité vitale forcée (CVF)
Délai: 9 mois
9 mois
Spirométrie : capacité vitale forcée (CVF)
Délai: 12 mois
12 mois
Spirométrie : FEV1/FVC
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Spirométrie : FEV1/FVC
Délai: 3 mois
3 mois
Spirométrie : FEV1/FVC
Délai: 6 mois
6 mois
Spirométrie : FEV1/FVC
Délai: 9 mois
9 mois
Spirométrie : FEV1/FVC
Délai: 12 mois
12 mois
Pléthysmographie pour les volumes pulmonaires : volume résiduel (VR)
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Pléthysmographie pour les volumes pulmonaires : volume résiduel (VR)
Délai: 3 mois
3 mois
Pléthysmographie pour les volumes pulmonaires : volume résiduel (VR)
Délai: 6 mois
6 mois
Pléthysmographie pour les volumes pulmonaires : volume résiduel (VR)
Délai: 9 mois
9 mois
Pléthysmographie pour les volumes pulmonaires : volume résiduel (VR)
Délai: 12 mois
12 mois
Pléthysmographie pour les volumes pulmonaires : capacité résiduelle fonctionnelle (FRC)
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Pléthysmographie pour les volumes pulmonaires : capacité résiduelle fonctionnelle (FRC)
Délai: 3 mois
3 mois
Pléthysmographie pour les volumes pulmonaires : capacité résiduelle fonctionnelle (FRC)
Délai: 6 mois
6 mois
Pléthysmographie pour les volumes pulmonaires : capacité résiduelle fonctionnelle (FRC)
Délai: 9 mois
9 mois
Pléthysmographie pour les volumes pulmonaires : capacité résiduelle fonctionnelle (FRC)
Délai: 12 mois
12 mois
Pléthysmographie pour les volumes pulmonaires : capacité pulmonaire totale (TLC)
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Pléthysmographie pour les volumes pulmonaires : capacité pulmonaire totale (TLC)
Délai: 3 mois
3 mois
Pléthysmographie pour les volumes pulmonaires : capacité pulmonaire totale (TLC)
Délai: 6 mois
6 mois
Pléthysmographie pour les volumes pulmonaires : capacité pulmonaire totale (TLC)
Délai: 9 mois
9 mois
Pléthysmographie pour les volumes pulmonaires : capacité pulmonaire totale (TLC)
Délai: 12 mois
12 mois
Pléthysmographie pour les volumes pulmonaires : RV/TLC
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Pléthysmographie pour les volumes pulmonaires : RV/TLC
Délai: 3 mois
3 mois
Pléthysmographie pour les volumes pulmonaires : RV/TLC
Délai: 6 mois
6 mois
Pléthysmographie pour les volumes pulmonaires : RV/TLC
Délai: 9 mois
9 mois
Pléthysmographie pour les volumes pulmonaires : RV/TLC
Délai: 12 mois
12 mois
Consommation de médicaments tout au long de l'étude.
Délai: 12 mois
12 mois
Le nombre d'événements indésirables sera enregistré tout au long de l'étude.
Délai: 12 mois
12 mois
Protéine de sécrétion cellulaire Serum Club
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Protéine de sécrétion cellulaire Serum Club
Délai: 12 mois
12 mois
Bactériologie des expectorations
Délai: Base de référence (jour 0)
Base de référence (jour 0)
Bactériologie des expectorations
Délai: 12 mois
12 mois
The number of mild exacerbations throughout follow-up
Délai: 12 months

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

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

Severe exacerbations require hospitalization.
12 months
COPD Assessment Test (CAT)
Délai: 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)
Délai: 3 months

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

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

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

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

For each hospitalization, the beginning and end dates will be recorded.
12 months
Clinical improvement
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline (day 0)

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

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

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

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

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

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Montpellier

Collaborateurs

Rheonova

Les enquêteurs

  • Directeur d'études: Jérémy Charriot, MD, University Hospital, Montpellier

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 février 2023

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

2 avril 2020

Première soumission répondant aux critères de contrôle qualité

5 avril 2020

Première publication (Réel)

9 avril 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RECHMPL19_0074

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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).

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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