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Chronische luchtwegaandoeningen, slijmreologie en exacerbaties (COPD-CARhE)

21 september 2026 bijgewerkt door: University Hospital, Montpellier

Chronische luchtwegaandoeningen, slijmreologie en exacerbaties: een gerandomiseerde, gecontroleerde studie bij COPD-patiënten

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
      • Bordeaux, Frankrijk
        • Werving
        • University Hospitals of Bordeaux
        • Hoofdonderzoeker:
          • Maéva Zysman, MD, PhD
      • Montpellier, Frankrijk, 34925
        • Werving
        • University Hospitals of Montpellier
        • Hoofdonderzoeker:
          • Jérémy Charriot, MD
        • Onderonderzoeker:
          • Arnaud Bourdin, MD, PhD
        • Onderonderzoeker:
          • Anne-Sophie Gamez, MD
        • Onderonderzoeker:
          • Jean Romain, MD
      • Toulouse, Frankrijk
        • Werving
        • University Hospitals of Toulouse
        • Hoofdonderzoeker:
          • Laurent Guilleminault, MD
        • Onderonderzoeker:
          • Alain Didier, MD, PhD
        • Onderonderzoeker:
          • Danielle Brouquieres, MD
        • Onderonderzoeker:
          • Nicolas Guibert, MD
        • Onderonderzoeker:
          • Sandrine Pontier Marchandise, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Azithromycin according to symptoms

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reologie: elasticiteitsmodulus van slijm (G ')
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Reologie: elasticiteitsmodulus van slijm (G ')
Tijdsspanne: 3 maanden
3 maanden
Reologie: elasticiteitsmodulus van slijm (G ')
Tijdsspanne: 6 maanden
6 maanden
Reologie: elasticiteitsmodulus van slijm (G ')
Tijdsspanne: 9 maanden
9 maanden
Reologie: elasticiteitsmodulus van slijm (G ')
Tijdsspanne: 12 maanden
12 maanden
Reologie: de stroperige module (G'')
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Reologie: de stroperige module (G'')
Tijdsspanne: 3 maanden
3 maanden
Reologie: de stroperige module (G'')
Tijdsspanne: 6 maanden
6 maanden
Reologie: de stroperige module (G'')
Tijdsspanne: 9 maanden
9 maanden
Reologie: de stroperige module (G'')
Tijdsspanne: 12 maanden
12 maanden
Reologie: de verhouding G '' / G '
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Reologie: de verhouding G '' / G '
Tijdsspanne: 3 maanden
3 maanden
Reologie: de verhouding G '' / G '
Tijdsspanne: 6 maanden
6 maanden
Reologie: de verhouding G '' / G '
Tijdsspanne: 9 maanden
9 maanden
Reologie: de verhouding G '' / G '
Tijdsspanne: 12 maanden
12 maanden
Reologie: de kritische beperking (tau-C).
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Reologie: de kritische beperking (tau-C).
Tijdsspanne: 3 maanden
3 maanden
Reologie: de kritische beperking (tau-C).
Tijdsspanne: 6 maanden
6 maanden
Reologie: de kritische beperking (tau-C).
Tijdsspanne: 9 maanden
9 maanden
Reologie: de kritische beperking (tau-C).
Tijdsspanne: 12 maanden
12 maanden
Spirometrie: geforceerd expiratoir volume in 1 minuut (FEV1)
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Spirometrie: geforceerd expiratoir volume in 1 minuut (FEV1)
Tijdsspanne: 3 maanden
3 maanden
Spirometrie: geforceerd expiratoir volume in 1 minuut (FEV1)
Tijdsspanne: 6 maanden
6 maanden
Spirometrie: geforceerd expiratoir volume in 1 minuut (FEV1)
Tijdsspanne: 9 maanden
9 maanden
Spirometrie: geforceerd expiratoir volume in 1 minuut (FEV1)
Tijdsspanne: 12 maanden
12 maanden
Spirometrie: geforceerde vitale capaciteit (FVC)
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Spirometrie: geforceerde vitale capaciteit (FVC)
Tijdsspanne: 3 maanden
3 maanden
Spirometrie: geforceerde vitale capaciteit (FVC)
Tijdsspanne: 6 maanden
6 maanden
Spirometrie: geforceerde vitale capaciteit (FVC)
Tijdsspanne: 9 maanden
9 maanden
Spirometrie: geforceerde vitale capaciteit (FVC)
Tijdsspanne: 12 maanden
12 maanden
Spirometrie: FEV1/FVC
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Spirometrie: FEV1/FVC
Tijdsspanne: 3 maanden
3 maanden
Spirometrie: FEV1/FVC
Tijdsspanne: 6 maanden
6 maanden
Spirometrie: FEV1/FVC
Tijdsspanne: 9 maanden
9 maanden
Spirometrie: FEV1/FVC
Tijdsspanne: 12 maanden
12 maanden
Plethysmografie voor longvolumes: restvolume (RV)
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Plethysmografie voor longvolumes: restvolume (RV)
Tijdsspanne: 3 maanden
3 maanden
Plethysmografie voor longvolumes: restvolume (RV)
Tijdsspanne: 6 maanden
6 maanden
Plethysmografie voor longvolumes: restvolume (RV)
Tijdsspanne: 9 maanden
9 maanden
Plethysmografie voor longvolumes: restvolume (RV)
Tijdsspanne: 12 maanden
12 maanden
Plethysmografie voor longvolumes: functionele restcapaciteit (FRC)
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Plethysmografie voor longvolumes: functionele restcapaciteit (FRC)
Tijdsspanne: 3 maanden
3 maanden
Plethysmografie voor longvolumes: functionele restcapaciteit (FRC)
Tijdsspanne: 6 maanden
6 maanden
Plethysmografie voor longvolumes: functionele restcapaciteit (FRC)
Tijdsspanne: 9 maanden
9 maanden
Plethysmografie voor longvolumes: functionele restcapaciteit (FRC)
Tijdsspanne: 12 maanden
12 maanden
Plethysmografie voor longvolumes: totale longcapaciteit (TLC)
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Plethysmografie voor longvolumes: totale longcapaciteit (TLC)
Tijdsspanne: 3 maanden
3 maanden
Plethysmografie voor longvolumes: totale longcapaciteit (TLC)
Tijdsspanne: 6 maanden
6 maanden
Plethysmografie voor longvolumes: totale longcapaciteit (TLC)
Tijdsspanne: 9 maanden
9 maanden
Plethysmografie voor longvolumes: totale longcapaciteit (TLC)
Tijdsspanne: 12 maanden
12 maanden
Plethysmografie voor longvolumes: RV/TLC
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Plethysmografie voor longvolumes: RV/TLC
Tijdsspanne: 3 maanden
3 maanden
Plethysmografie voor longvolumes: RV/TLC
Tijdsspanne: 6 maanden
6 maanden
Plethysmografie voor longvolumes: RV/TLC
Tijdsspanne: 9 maanden
9 maanden
Plethysmografie voor longvolumes: RV/TLC
Tijdsspanne: 12 maanden
12 maanden
Drugsgebruik tijdens het onderzoek.
Tijdsspanne: 12 maanden
12 maanden
Het aantal bijwerkingen zal tijdens het onderzoek worden geregistreerd.
Tijdsspanne: 12 maanden
12 maanden
Serum Club-celsecretie-eiwit
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Serum Club-celsecretie-eiwit
Tijdsspanne: 12 maanden
12 maanden
Sputum bacteriologie
Tijdsspanne: Basislijn (dag 0)
Basislijn (dag 0)
Sputum bacteriologie
Tijdsspanne: 12 maanden
12 maanden
The number of mild exacerbations throughout follow-up
Tijdsspanne: 12 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Montpellier

Medewerkers

Rheonova

Onderzoekers

  • Studie directeur: Jérémy Charriot, MD, University Hospital, Montpellier

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 februari 2023

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

2 april 2020

Eerst ingediend dat voldeed aan de QC-criteria

5 april 2020

Eerst geplaatst (Werkelijk)

9 april 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RECHMPL19_0074

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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