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Doença Crônica das Vias Aéreas, Reologia do Muco e Exacerbações (COPD-CARhE)

21 de setembro de 2026 atualizado por: University Hospital, Montpellier

Doença Crônica das Vias Aéreas, Reologia do Muco e Exacerbações: um Estudo Randomizado e Controlado de Pacientes com DPOC

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

72

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Azithromycin according to symptoms

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

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Reologia: módulo de elasticidade do muco (G')
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Reologia: módulo de elasticidade do muco (G')
Prazo: 3 meses
3 meses
Reologia: módulo de elasticidade do muco (G')
Prazo: 6 meses
6 meses
Reologia: módulo de elasticidade do muco (G')
Prazo: 9 meses
9 meses
Reologia: módulo de elasticidade do muco (G')
Prazo: 12 meses
12 meses
Reologia: o módulo viscoso (G '')
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Reologia: o módulo viscoso (G '')
Prazo: 3 meses
3 meses
Reologia: o módulo viscoso (G '')
Prazo: 6 meses
6 meses
Reologia: o módulo viscoso (G '')
Prazo: 9 meses
9 meses
Reologia: o módulo viscoso (G '')
Prazo: 12 meses
12 meses
Reologia: A razão G''/G'
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Reologia: A razão G''/G'
Prazo: 3 meses
3 meses
Reologia: A razão G''/G'
Prazo: 6 meses
6 meses
Reologia: A razão G''/G'
Prazo: 9 meses
9 meses
Reologia: A razão G''/G'
Prazo: 12 meses
12 meses
Reologia: a restrição crítica (tau-C).
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Reologia: a restrição crítica (tau-C).
Prazo: 3 meses
3 meses
Reologia: a restrição crítica (tau-C).
Prazo: 6 meses
6 meses
Reologia: a restrição crítica (tau-C).
Prazo: 9 meses
9 meses
Reologia: a restrição crítica (tau-C).
Prazo: 12 meses
12 meses
Espirometria: volume expiratório forçado em 1 minuto (VEF1)
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Espirometria: volume expiratório forçado em 1 minuto (VEF1)
Prazo: 3 meses
3 meses
Espirometria: volume expiratório forçado em 1 minuto (VEF1)
Prazo: 6 meses
6 meses
Espirometria: volume expiratório forçado em 1 minuto (VEF1)
Prazo: 9 meses
9 meses
Espirometria: volume expiratório forçado em 1 minuto (VEF1)
Prazo: 12 meses
12 meses
Espirometria: capacidade vital forçada (CVF)
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Espirometria: capacidade vital forçada (CVF)
Prazo: 3 meses
3 meses
Espirometria: capacidade vital forçada (CVF)
Prazo: 6 meses
6 meses
Espirometria: capacidade vital forçada (CVF)
Prazo: 9 meses
9 meses
Espirometria: capacidade vital forçada (CVF)
Prazo: 12 meses
12 meses
Espirometria: VEF1/CVF
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Espirometria: VEF1/CVF
Prazo: 3 meses
3 meses
Espirometria: VEF1/CVF
Prazo: 6 meses
6 meses
Espirometria: VEF1/CVF
Prazo: 9 meses
9 meses
Espirometria: VEF1/CVF
Prazo: 12 meses
12 meses
Pletismografia para volumes pulmonares: volume residual (VR)
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Pletismografia para volumes pulmonares: volume residual (VR)
Prazo: 3 meses
3 meses
Pletismografia para volumes pulmonares: volume residual (VR)
Prazo: 6 meses
6 meses
Pletismografia para volumes pulmonares: volume residual (VR)
Prazo: 9 meses
9 meses
Pletismografia para volumes pulmonares: volume residual (VR)
Prazo: 12 meses
12 meses
Pletismografia para volumes pulmonares: capacidade residual funcional (CRF)
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Pletismografia para volumes pulmonares: capacidade residual funcional (CRF)
Prazo: 3 meses
3 meses
Pletismografia para volumes pulmonares: capacidade residual funcional (CRF)
Prazo: 6 meses
6 meses
Pletismografia para volumes pulmonares: capacidade residual funcional (CRF)
Prazo: 9 meses
9 meses
Pletismografia para volumes pulmonares: capacidade residual funcional (CRF)
Prazo: 12 meses
12 meses
Pletismografia para volumes pulmonares: capacidade pulmonar total (CPT)
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Pletismografia para volumes pulmonares: capacidade pulmonar total (CPT)
Prazo: 3 meses
3 meses
Pletismografia para volumes pulmonares: capacidade pulmonar total (CPT)
Prazo: 6 meses
6 meses
Pletismografia para volumes pulmonares: capacidade pulmonar total (CPT)
Prazo: 9 meses
9 meses
Pletismografia para volumes pulmonares: capacidade pulmonar total (CPT)
Prazo: 12 meses
12 meses
Pletismografia para volumes pulmonares: RV/TLC
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Pletismografia para volumes pulmonares: RV/TLC
Prazo: 3 meses
3 meses
Pletismografia para volumes pulmonares: RV/TLC
Prazo: 6 meses
6 meses
Pletismografia para volumes pulmonares: RV/TLC
Prazo: 9 meses
9 meses
Pletismografia para volumes pulmonares: RV/TLC
Prazo: 12 meses
12 meses
Consumo de drogas ao longo do estudo.
Prazo: 12 meses
12 meses
O número de eventos adversos será registrado ao longo do estudo.
Prazo: 12 meses
12 meses
Proteína secretora da célula Serum Club
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Proteína secretora da célula Serum Club
Prazo: 12 meses
12 meses
Bacteriologia do escarro
Prazo: Linha de base (dia 0)
Linha de base (dia 0)
Bacteriologia do escarro
Prazo: 12 meses
12 meses
The number of mild exacerbations throughout follow-up
Prazo: 12 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Montpellier

Colaboradores

Rheonova

Investigadores

  • Diretor de estudo: Jérémy Charriot, MD, University Hospital, Montpellier

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de fevereiro de 2023

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de abril de 2020

Primeira postagem (Real)

9 de abril de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RECHMPL19_0074

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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).

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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