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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
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.
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.
University Hospitals of Bordeaux
Bordeaux, France
RECRUITINGUniversity Hospitals of Montpellier
Montpellier, France
RECRUITINGUniversity Hospitals of Toulouse
Toulouse, France
RECRUITINGThe main outcome measure is the number of exacerbations over the 12 months of follow-up.
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)."
Time frame: 12 months
The number of mild exacerbations throughout follow-up
A mild exacerbation does not require new additional medicine.
Time frame: 12 months
The number of moderate exacerbations throughout follow-up
Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization).
Time frame: 12 months
The number of severe exacerbations throughout follow-up
Severe exacerbations require hospitalization.
Time frame: 12 months
COPD Assessment Test (CAT)
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: Baseline (Day 0)
COPD Assessment Test (CAT)
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: 3 months
COPD Assessment Test (CAT)
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
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Time frame: 6 months
COPD Assessment Test (CAT)
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: 9 months
COPD Assessment Test (CAT)
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: 12 months
Sino Nasal Outcome Test 22
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).
Time frame: Baseline (Day 0)
Sino Nasal Outcome Test 22
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).
Time frame: 3 months
Sino Nasal Outcome Test 22
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).
Time frame: 6 months
Sino Nasal Outcome Test 22
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).
Time frame: 9 months
Sino Nasal Outcome Test 22
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).
Time frame: 12 months
Cough and sputum assessment questionnaire (CASA-Q)
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.
Time frame: Baseline (Day 0)
Cough and sputum assessment questionnaire (CASA-Q)
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.
Time frame: 3 months
Cough and sputum assessment questionnaire (CASA-Q)
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.
Time frame: 6 months
Cough and sputum assessment questionnaire (CASA-Q)
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.
Time frame: 9 months
Cough and sputum assessment questionnaire (CASA-Q)
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.
Time frame: 12 months
Visual analogue scale for dyspnea
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Time frame: Baseline (Day 0)
Visual analogue scale for dyspnea
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Time frame: 3 months
Visual analogue scale for dyspnea
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Time frame: 6 months
Visual analogue scale for dyspnea
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Time frame: 9 months
Visual analogue scale for dyspnea
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of dyspnea possible).
Time frame: 12 months
Visual analogue scale for coughing
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Time frame: Baseline (Day 0)
Visual analogue scale for coughing
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Time frame: 3 months
Visual analogue scale for coughing
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Time frame: 6 months
Visual analogue scale for coughing
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Time frame: 9 months
Visual analogue scale for coughing
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of coughing possible).
Time frame: 12 months
Visual analogue scale for sputum production
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Time frame: Baseline (Day 0)
Visual analogue scale for sputum production
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Time frame: 3 months
Visual analogue scale for sputum production
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Time frame: 6 months
Visual analogue scale for sputum production
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Time frame: 9 months
Visual analogue scale for sputum production
A patient-reported visual analogue scale (VAS) starting at 0 (no symptoms) and ending at 100 (the worst possible level of sputum production possible).
Time frame: 12 months
Rheology: modulus of elasticity of mucus (G ')
Time frame: Baseline (Day 0)
Rheology: modulus of elasticity of mucus (G ')
Time frame: 3 months
Rheology: modulus of elasticity of mucus (G ')
Time frame: 6 months
Rheology: modulus of elasticity of mucus (G ')
Time frame: 9 months
Rheology: modulus of elasticity of mucus (G ')
Time frame: 12 months
Rheology: the viscous module (G '')
Time frame: Baseline (Day 0)
Rheology: the viscous module (G '')
Time frame: 3 months
Rheology: the viscous module (G '')
Time frame: 6 months
Rheology: the viscous module (G '')
Time frame: 9 months
Rheology: the viscous module (G '')
Time frame: 12 months
Rheology: The ratio G '' / G '
Time frame: Baseline (Day 0)
Rheology: The ratio G '' / G '
Time frame: 3 months
Rheology: The ratio G '' / G '
Time frame: 6 months
Rheology: The ratio G '' / G '
Time frame: 9 months
Rheology: The ratio G '' / G '
Time frame: 12 months
Rheology: the critical constraint (tau-C).
Time frame: Baseline (Day 0)
Rheology: the critical constraint (tau-C).
Time frame: 3 months
Rheology: the critical constraint (tau-C).
Time frame: 6 months
Rheology: the critical constraint (tau-C).
Time frame: 9 months
Rheology: the critical constraint (tau-C).
Time frame: 12 months
Spirometry: forced expiratory volume in 1 minute (FEV1)
Time frame: Baseline (day 0)
Spirometry: forced expiratory volume in 1 minute (FEV1)
Time frame: 3 months
Spirometry: forced expiratory volume in 1 minute (FEV1)
Time frame: 6 months
Spirometry: forced expiratory volume in 1 minute (FEV1)
Time frame: 9 months
Spirometry: forced expiratory volume in 1 minute (FEV1)
Time frame: 12 months
Spirometry: forced vital capacity (FVC)
Time frame: Baseline (day 0)
Spirometry: forced vital capacity (FVC)
Time frame: 3 months
Spirometry: forced vital capacity (FVC)
Time frame: 6 months
Spirometry: forced vital capacity (FVC)
Time frame: 9 months
Spirometry: forced vital capacity (FVC)
Time frame: 12 months
Spirometry: FEV1/FVC
Time frame: Baseline (day 0)
Spirometry: FEV1/FVC
Time frame: 3 months
Spirometry: FEV1/FVC
Time frame: 6 months
Spirometry: FEV1/FVC
Time frame: 9 months
Spirometry: FEV1/FVC
Time frame: 12 months
Plethysmography for lung volumes: residual volume (RV)
Time frame: Baseline (day 0)
Plethysmography for lung volumes: residual volume (RV)
Time frame: 3 months
Plethysmography for lung volumes: residual volume (RV)
Time frame: 6 months
Plethysmography for lung volumes: residual volume (RV)
Time frame: 9 months
Plethysmography for lung volumes: residual volume (RV)
Time frame: 12 months
Plethysmography for lung volumes: functional residual capacity (FRC)
Time frame: Baseline (day 0)
Plethysmography for lung volumes: functional residual capacity (FRC)
Time frame: 3 months
Plethysmography for lung volumes: functional residual capacity (FRC)
Time frame: 6 months
Plethysmography for lung volumes: functional residual capacity (FRC)
Time frame: 9 months
Plethysmography for lung volumes: functional residual capacity (FRC)
Time frame: 12 months
Plethysmography for lung volumes: total lung capacity (TLC)
Time frame: Baseline (day 0)
Plethysmography for lung volumes: total lung capacity (TLC)
Time frame: 3 months
Plethysmography for lung volumes: total lung capacity (TLC)
Time frame: 6 months
Plethysmography for lung volumes: total lung capacity (TLC)
Time frame: 9 months
Plethysmography for lung volumes: total lung capacity (TLC)
Time frame: 12 months
Plethysmography for lung volumes: RV/TLC
Time frame: Baseline (day 0)
Plethysmography for lung volumes: RV/TLC
Time frame: 3 months
Plethysmography for lung volumes: RV/TLC
Time frame: 6 months
Plethysmography for lung volumes: RV/TLC
Time frame: 9 months
Plethysmography for lung volumes: RV/TLC
Time frame: 12 months
Drug consumption throughout the study.
Time frame: 12 months
The number of adverse events will be recorded throughout the study.
Time frame: 12 months
Episodes of exacerbation throughout the study
For each exacerbation, the beginning and end dates will be recorded.
Time frame: 12 months
Episodes of hospitalization throughout the study
For each hospitalization, the beginning and end dates will be recorded.
Time frame: 12 months
Clinical improvement
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.
Time frame: 12 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
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.
Time frame: Baseline (day 0)
Medical outcomes study 36-Item Short Form Survey (SF-36)
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.
Time frame: 3 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
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.
Time frame: 6 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
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.
Time frame: 9 months
Medical outcomes study 36-Item Short Form Survey (SF-36)
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.
Time frame: 12 months
EQ-5D-5L
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.
Time frame: Baseline (day 0)
EQ-5D-5L
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.
Time frame: 3 months
EQ-5D-5L
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.
Time frame: 6 months
EQ-5D-5L
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.
Time frame: 9 months
EQ-5D-5L
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.
Time frame: 12 months
St-George's Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: Baseline (day 0)
St-George's Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 3 months
St-George's Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 6 months
St-George's Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 9 months
St-George's Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 12 months
Blood cell differential: neutrophil levels
A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Time frame: Baseline (day 0)
Blood cell differential: eosinophil levels
A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Time frame: Baseline (day 0)
Blood cell differential: neutrophil levels
A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Time frame: 12 months
Blood cell differential: eosinophil levels
A complete blood cell differential will be taken, including neutrophilia and eosinophilia.
Time frame: 12 months
Serum Club cell secretory protein
Time frame: Baseline (day 0)
Serum Club cell secretory protein
Time frame: 12 months
Sputum bacteriology
Time frame: Baseline (day 0)
Sputum bacteriology
Time frame: 12 months