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Malattia cronica delle vie aeree, reologia del muco e riacutizzazioni (COPD-CARhE)

21 settembre 2026 aggiornato da: University Hospital, Montpellier

Malattia cronica delle vie aeree, reologia del muco e riacutizzazioni: uno studio controllato randomizzato su pazienti con BPCO

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Bordeaux, Francia
        • Reclutamento
        • University Hospitals of Bordeaux
        • Investigatore principale:
          • Maéva Zysman, MD, PhD
      • Montpellier, Francia, 34925
        • Reclutamento
        • University Hospitals of Montpellier
        • Investigatore principale:
          • Jérémy Charriot, MD
        • Sub-investigatore:
          • Arnaud Bourdin, MD, PhD
        • Sub-investigatore:
          • Anne-Sophie Gamez, MD
        • Sub-investigatore:
          • Jean Romain, MD
      • Toulouse, Francia
        • Reclutamento
        • University Hospitals of Toulouse
        • Investigatore principale:
          • Laurent Guilleminault, MD
        • Sub-investigatore:
          • Alain Didier, MD, PhD
        • Sub-investigatore:
          • Danielle Brouquieres, MD
        • Sub-investigatore:
          • Nicolas Guibert, MD
        • Sub-investigatore:
          • Sandrine Pontier Marchandise, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Azithromycin according to symptoms

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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reologia: modulo di elasticità del muco (G ')
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Reologia: modulo di elasticità del muco (G ')
Lasso di tempo: 3 mesi
3 mesi
Reologia: modulo di elasticità del muco (G ')
Lasso di tempo: 6 mesi
6 mesi
Reologia: modulo di elasticità del muco (G ')
Lasso di tempo: 9 mesi
9 mesi
Reologia: modulo di elasticità del muco (G ')
Lasso di tempo: 12 mesi
12 mesi
Reologia: il modulo viscoso (G'')
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Reologia: il modulo viscoso (G'')
Lasso di tempo: 3 mesi
3 mesi
Reologia: il modulo viscoso (G'')
Lasso di tempo: 6 mesi
6 mesi
Reologia: il modulo viscoso (G'')
Lasso di tempo: 9 mesi
9 mesi
Reologia: il modulo viscoso (G'')
Lasso di tempo: 12 mesi
12 mesi
Reologia: il rapporto G''/G'
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Reologia: il rapporto G''/G'
Lasso di tempo: 3 mesi
3 mesi
Reologia: il rapporto G''/G'
Lasso di tempo: 6 mesi
6 mesi
Reologia: il rapporto G''/G'
Lasso di tempo: 9 mesi
9 mesi
Reologia: il rapporto G''/G'
Lasso di tempo: 12 mesi
12 mesi
Reologia: il vincolo critico (tau-C).
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Reologia: il vincolo critico (tau-C).
Lasso di tempo: 3 mesi
3 mesi
Reologia: il vincolo critico (tau-C).
Lasso di tempo: 6 mesi
6 mesi
Reologia: il vincolo critico (tau-C).
Lasso di tempo: 9 mesi
9 mesi
Reologia: il vincolo critico (tau-C).
Lasso di tempo: 12 mesi
12 mesi
Spirometria: volume espiratorio forzato in 1 minuto (FEV1)
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Spirometria: volume espiratorio forzato in 1 minuto (FEV1)
Lasso di tempo: 3 mesi
3 mesi
Spirometria: volume espiratorio forzato in 1 minuto (FEV1)
Lasso di tempo: 6 mesi
6 mesi
Spirometria: volume espiratorio forzato in 1 minuto (FEV1)
Lasso di tempo: 9 mesi
9 mesi
Spirometria: volume espiratorio forzato in 1 minuto (FEV1)
Lasso di tempo: 12 mesi
12 mesi
Spirometria: capacità vitale forzata (FVC)
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Spirometria: capacità vitale forzata (FVC)
Lasso di tempo: 3 mesi
3 mesi
Spirometria: capacità vitale forzata (FVC)
Lasso di tempo: 6 mesi
6 mesi
Spirometria: capacità vitale forzata (FVC)
Lasso di tempo: 9 mesi
9 mesi
Spirometria: capacità vitale forzata (FVC)
Lasso di tempo: 12 mesi
12 mesi
Spirometria: FEV1/FVC
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Spirometria: FEV1/FVC
Lasso di tempo: 3 mesi
3 mesi
Spirometria: FEV1/FVC
Lasso di tempo: 6 mesi
6 mesi
Spirometria: FEV1/FVC
Lasso di tempo: 9 mesi
9 mesi
Spirometria: FEV1/FVC
Lasso di tempo: 12 mesi
12 mesi
Pletismografia per volumi polmonari: volume residuo (RV)
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Pletismografia per volumi polmonari: volume residuo (RV)
Lasso di tempo: 3 mesi
3 mesi
Pletismografia per volumi polmonari: volume residuo (RV)
Lasso di tempo: 6 mesi
6 mesi
Pletismografia per volumi polmonari: volume residuo (RV)
Lasso di tempo: 9 mesi
9 mesi
Pletismografia per volumi polmonari: volume residuo (RV)
Lasso di tempo: 12 mesi
12 mesi
Pletismografia per volumi polmonari: capacità funzionale residua (FRC)
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Pletismografia per volumi polmonari: capacità funzionale residua (FRC)
Lasso di tempo: 3 mesi
3 mesi
Pletismografia per volumi polmonari: capacità funzionale residua (FRC)
Lasso di tempo: 6 mesi
6 mesi
Pletismografia per volumi polmonari: capacità funzionale residua (FRC)
Lasso di tempo: 9 mesi
9 mesi
Pletismografia per volumi polmonari: capacità funzionale residua (FRC)
Lasso di tempo: 12 mesi
12 mesi
Pletismografia per volumi polmonari: capacità polmonare totale (TLC)
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Pletismografia per volumi polmonari: capacità polmonare totale (TLC)
Lasso di tempo: 3 mesi
3 mesi
Pletismografia per volumi polmonari: capacità polmonare totale (TLC)
Lasso di tempo: 6 mesi
6 mesi
Pletismografia per volumi polmonari: capacità polmonare totale (TLC)
Lasso di tempo: 9 mesi
9 mesi
Pletismografia per volumi polmonari: capacità polmonare totale (TLC)
Lasso di tempo: 12 mesi
12 mesi
Pletismografia per volumi polmonari: RV/TLC
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Pletismografia per volumi polmonari: RV/TLC
Lasso di tempo: 3 mesi
3 mesi
Pletismografia per volumi polmonari: RV/TLC
Lasso di tempo: 6 mesi
6 mesi
Pletismografia per volumi polmonari: RV/TLC
Lasso di tempo: 9 mesi
9 mesi
Pletismografia per volumi polmonari: RV/TLC
Lasso di tempo: 12 mesi
12 mesi
Consumo di droghe durante lo studio.
Lasso di tempo: 12 mesi
12 mesi
Il numero di eventi avversi verrà registrato durante lo studio.
Lasso di tempo: 12 mesi
12 mesi
Proteina secretoria delle cellule del club del siero
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Proteina secretoria delle cellule del club del siero
Lasso di tempo: 12 mesi
12 mesi
Batteriologia dell'espettorato
Lasso di tempo: Basale (giorno 0)
Basale (giorno 0)
Batteriologia dell'espettorato
Lasso di tempo: 12 mesi
12 mesi
The number of mild exacerbations throughout follow-up
Lasso di tempo: 12 months

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

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

Severe exacerbations require hospitalization.
12 months
COPD Assessment Test (CAT)
Lasso di tempo: 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)
Lasso di tempo: 3 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Montpellier

Collaboratori

Rheonova

Investigatori

  • Direttore dello studio: Jérémy Charriot, MD, University Hospital, Montpellier

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 febbraio 2023

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

2 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

5 aprile 2020

Primo Inserito (Effettivo)

9 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RECHMPL19_0074

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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).

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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