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Kronisk luftveissykdom, slimreologi og eksaserbasjoner (COPD-CARhE)

21. september 2026 oppdatert av: University Hospital, Montpellier

Kronisk luftveissykdom, slimreologi og eksaserbasjoner: en randomisert kontrollert studie av KOLS-pasienter

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

72

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Azithromycin according to symptoms

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reologi: elastisitetsmodul for slim (G ')
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Reologi: elastisitetsmodul for slim (G ')
Tidsramme: 3 måneder
3 måneder
Reologi: elastisitetsmodul for slim (G ')
Tidsramme: 6 måneder
6 måneder
Reologi: elastisitetsmodul for slim (G ')
Tidsramme: 9 måneder
9 måneder
Reologi: elastisitetsmodul for slim (G ')
Tidsramme: 12 måneder
12 måneder
Reologi: den viskøse modulen (G '')
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Reologi: den viskøse modulen (G '')
Tidsramme: 3 måneder
3 måneder
Reologi: den viskøse modulen (G '')
Tidsramme: 6 måneder
6 måneder
Reologi: den viskøse modulen (G '')
Tidsramme: 9 måneder
9 måneder
Reologi: den viskøse modulen (G '')
Tidsramme: 12 måneder
12 måneder
Reologi: Forholdet G '' / G '
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Reologi: forholdet G '' / G '
Tidsramme: 3 måneder
3 måneder
Reologi: Forholdet G '' / G '
Tidsramme: 6 måneder
6 måneder
Reologi: Forholdet G '' / G '
Tidsramme: 9 måneder
9 måneder
Reologi: Forholdet G '' / G '
Tidsramme: 12 måneder
12 måneder
Reologi: den kritiske begrensningen (tau-C).
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Reologi: den kritiske begrensningen (tau-C).
Tidsramme: 3 måneder
3 måneder
Reologi: den kritiske begrensningen (tau-C).
Tidsramme: 6 måneder
6 måneder
Reologi: den kritiske begrensningen (tau-C).
Tidsramme: 9 måneder
9 måneder
Reologi: den kritiske begrensningen (tau-C).
Tidsramme: 12 måneder
12 måneder
Spirometri: tvunget ekspirasjonsvolum på 1 minutt (FEV1)
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Spirometri: tvunget ekspirasjonsvolum på 1 minutt (FEV1)
Tidsramme: 3 måneder
3 måneder
Spirometri: tvunget ekspirasjonsvolum på 1 minutt (FEV1)
Tidsramme: 6 måneder
6 måneder
Spirometri: tvunget ekspirasjonsvolum på 1 minutt (FEV1)
Tidsramme: 9 måneder
9 måneder
Spirometri: tvunget ekspirasjonsvolum på 1 minutt (FEV1)
Tidsramme: 12 måneder
12 måneder
Spirometri: tvungen vital kapasitet (FVC)
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Spirometri: tvungen vital kapasitet (FVC)
Tidsramme: 3 måneder
3 måneder
Spirometri: tvungen vital kapasitet (FVC)
Tidsramme: 6 måneder
6 måneder
Spirometri: tvungen vital kapasitet (FVC)
Tidsramme: 9 måneder
9 måneder
Spirometri: tvungen vital kapasitet (FVC)
Tidsramme: 12 måneder
12 måneder
Spirometri: FEV1/FVC
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Spirometri: FEV1/FVC
Tidsramme: 3 måneder
3 måneder
Spirometri: FEV1/FVC
Tidsramme: 6 måneder
6 måneder
Spirometri: FEV1/FVC
Tidsramme: 9 måneder
9 måneder
Spirometri: FEV1/FVC
Tidsramme: 12 måneder
12 måneder
Pletysmografi for lungevolum: restvolum (RV)
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Pletysmografi for lungevolum: restvolum (RV)
Tidsramme: 3 måneder
3 måneder
Pletysmografi for lungevolum: restvolum (RV)
Tidsramme: 6 måneder
6 måneder
Pletysmografi for lungevolum: restvolum (RV)
Tidsramme: 9 måneder
9 måneder
Pletysmografi for lungevolum: restvolum (RV)
Tidsramme: 12 måneder
12 måneder
Pletysmografi for lungevolumer: funksjonell restkapasitet (FRC)
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Pletysmografi for lungevolumer: funksjonell restkapasitet (FRC)
Tidsramme: 3 måneder
3 måneder
Pletysmografi for lungevolumer: funksjonell restkapasitet (FRC)
Tidsramme: 6 måneder
6 måneder
Pletysmografi for lungevolumer: funksjonell restkapasitet (FRC)
Tidsramme: 9 måneder
9 måneder
Pletysmografi for lungevolumer: funksjonell restkapasitet (FRC)
Tidsramme: 12 måneder
12 måneder
Pletysmografi for lungevolum: total lungekapasitet (TLC)
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Pletysmografi for lungevolum: total lungekapasitet (TLC)
Tidsramme: 3 måneder
3 måneder
Pletysmografi for lungevolum: total lungekapasitet (TLC)
Tidsramme: 6 måneder
6 måneder
Pletysmografi for lungevolum: total lungekapasitet (TLC)
Tidsramme: 9 måneder
9 måneder
Pletysmografi for lungevolum: total lungekapasitet (TLC)
Tidsramme: 12 måneder
12 måneder
Pletysmografi for lungevolumer: RV/TLC
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Pletysmografi for lungevolumer: RV/TLC
Tidsramme: 3 måneder
3 måneder
Pletysmografi for lungevolumer: RV/TLC
Tidsramme: 6 måneder
6 måneder
Pletysmografi for lungevolumer: RV/TLC
Tidsramme: 9 måneder
9 måneder
Pletysmografi for lungevolumer: RV/TLC
Tidsramme: 12 måneder
12 måneder
Legemiddelforbruk gjennom hele studien.
Tidsramme: 12 måneder
12 måneder
Antall uønskede hendelser vil bli registrert gjennom hele studien.
Tidsramme: 12 måneder
12 måneder
Serum Club celle sekretorisk protein
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Serum Club celle sekretorisk protein
Tidsramme: 12 måneder
12 måneder
Sputumbakteriologi
Tidsramme: Grunnlinje (dag 0)
Grunnlinje (dag 0)
Sputumbakteriologi
Tidsramme: 12 måneder
12 måneder
The number of mild exacerbations throughout follow-up
Tidsramme: 12 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Montpellier

Samarbeidspartnere

Rheonova

Etterforskere

  • Studieleder: Jérémy Charriot, MD, University Hospital, Montpellier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. februar 2023

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

2. april 2020

Først innsendt som oppfylte QC-kriteriene

5. april 2020

Først lagt ut (Faktiske)

9. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RECHMPL19_0074

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere