AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 4COPD-CARhENCT04339270

Chronic Airway Disease, Mucus Rheology and Exacerbations

A Phase 4 study testing Azithropycin according to symptoms and Azithromycin according to rheology or symptoms in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Azithropycin according to symptoms and Azithromycin according to rheology or symptoms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
3 sitesFrance
Study dates
3 Feb 2023to Feb 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • >=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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jérémy Charriot, MD contact

04 67 33 67 33

j-charriot@chu-montpellier.fr

Arnaud BOURDIN, MD contact

04 67 33 67 33

a-bourdin@chu-montpellier.fr

France3 sites, 3 recruiting

  • University Hospitals of Bordeaux

    Bordeaux

    Maéva Zysman, MD, PhD

    Recruiting

  • University Hospitals of Montpellier

    Montpellier, 34925

    Jérémy Charriot, MD

    Arnaud Bourdin, MD, PhD

    Recruiting

  • University Hospitals of Toulouse

    Toulouse

    Laurent Guilleminault, MD

    Alain Didier, MD, PhD

    Recruiting

Other trials in France

About this study

Official title: Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients

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.

Read the detailed description

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).
Being tested
Azithropycin according to symptoms, Azithromycin according to rheology or symptoms
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithropycin according to symptomsDrug

    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.

  • Azithromycin according to rheology or symptomsDrug

    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.
Study groups in NCT04339270
Study groupRoleWhat they receive
Azithromycin according to symptomsActive comparatorPatients randomized to this arm will be prescribed azithromycin in function of their symptoms.
Receives: Drug: Azithropycin according to symptoms
Azithromycin according to rheologyExperimentalPatients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.
Receives: Drug: Azithromycin according to rheology or symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 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)."

    Measured: 12 months

Secondary outcomes (116)

  1. The number of mild exacerbations throughout follow-up

    A mild exacerbation does not require new additional medicine.

    Measured: 12 months

  2. The number of moderate exacerbations throughout follow-up

    Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization).

    Measured: 12 months

  3. The number of severe exacerbations throughout follow-up

    Severe exacerbations require hospitalization.

    Measured: 12 months

  4. COPD Assessment Test (CAT)

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: Baseline (Day 0)

  5. COPD Assessment Test (CAT)

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 3 months

  6. COPD Assessment Test (CAT)

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 6 months

  7. COPD Assessment Test (CAT)

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 9 months

  8. COPD Assessment Test (CAT)

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 12 months

  9. 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).

    Measured: Baseline (Day 0)

  10. 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).

    Measured: 3 months

  11. 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).

    Measured: 6 months

  12. 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).

    Measured: 9 months

  13. 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).

    Measured: 12 months

  14. 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.

    Measured: Baseline (Day 0)

  15. 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.

    Measured: 3 months

  16. 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.

    Measured: 6 months

  17. 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.

    Measured: 9 months

  18. 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.

    Measured: 12 months

  19. 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).

    Measured: Baseline (Day 0)

  20. 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).

    Measured: 3 months

  21. 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).

    Measured: 6 months

  22. 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).

    Measured: 9 months

  23. 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).

    Measured: 12 months

  24. 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).

    Measured: Baseline (Day 0)

  25. 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).

    Measured: 3 months

  26. 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).

    Measured: 6 months

  27. 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).

    Measured: 9 months

  28. 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).

    Measured: 12 months

  29. 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).

    Measured: Baseline (Day 0)

  30. 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).

    Measured: 3 months

  31. 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).

    Measured: 6 months

  32. 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).

    Measured: 9 months

  33. 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).

    Measured: 12 months

  34. Rheology: modulus of elasticity of mucus (G ')

    Measured: Baseline (Day 0)

  35. Rheology: modulus of elasticity of mucus (G ')

    Measured: 3 months

  36. Rheology: modulus of elasticity of mucus (G ')

    Measured: 6 months

  37. Rheology: modulus of elasticity of mucus (G ')

    Measured: 9 months

  38. Rheology: modulus of elasticity of mucus (G ')

    Measured: 12 months

  39. Rheology: the viscous module (G '')

    Measured: Baseline (Day 0)

  40. Rheology: the viscous module (G '')

    Measured: 3 months

  41. Rheology: the viscous module (G '')

    Measured: 6 months

  42. Rheology: the viscous module (G '')

    Measured: 9 months

  43. Rheology: the viscous module (G '')

    Measured: 12 months

  44. Rheology: The ratio G '' / G '

    Measured: Baseline (Day 0)

  45. Rheology: The ratio G '' / G '

    Measured: 3 months

  46. Rheology: The ratio G '' / G '

    Measured: 6 months

  47. Rheology: The ratio G '' / G '

    Measured: 9 months

  48. Rheology: The ratio G '' / G '

    Measured: 12 months

  49. Rheology: the critical constraint (tau-C).

    Measured: Baseline (Day 0)

  50. Rheology: the critical constraint (tau-C).

    Measured: 3 months

  51. Rheology: the critical constraint (tau-C).

    Measured: 6 months

  52. Rheology: the critical constraint (tau-C).

    Measured: 9 months

  53. Rheology: the critical constraint (tau-C).

    Measured: 12 months

  54. Spirometry: forced expiratory volume in 1 minute (FEV1)

    Measured: Baseline (day 0)

  55. Spirometry: forced expiratory volume in 1 minute (FEV1)

    Measured: 3 months

  56. Spirometry: forced expiratory volume in 1 minute (FEV1)

    Measured: 6 months

  57. Spirometry: forced expiratory volume in 1 minute (FEV1)

    Measured: 9 months

  58. Spirometry: forced expiratory volume in 1 minute (FEV1)

    Measured: 12 months

  59. Spirometry: forced vital capacity (FVC)

    Measured: Baseline (day 0)

  60. Spirometry: forced vital capacity (FVC)

    Measured: 3 months

  61. Spirometry: forced vital capacity (FVC)

    Measured: 6 months

  62. Spirometry: forced vital capacity (FVC)

    Measured: 9 months

  63. Spirometry: forced vital capacity (FVC)

    Measured: 12 months

  64. Spirometry: FEV1/FVC

    Measured: Baseline (day 0)

  65. Spirometry: FEV1/FVC

    Measured: 3 months

  66. Spirometry: FEV1/FVC

    Measured: 6 months

  67. Spirometry: FEV1/FVC

    Measured: 9 months

  68. Spirometry: FEV1/FVC

    Measured: 12 months

  69. Plethysmography for lung volumes: residual volume (RV)

    Measured: Baseline (day 0)

  70. Plethysmography for lung volumes: residual volume (RV)

    Measured: 3 months

  71. Plethysmography for lung volumes: residual volume (RV)

    Measured: 6 months

  72. Plethysmography for lung volumes: residual volume (RV)

    Measured: 9 months

  73. Plethysmography for lung volumes: residual volume (RV)

    Measured: 12 months

  74. Plethysmography for lung volumes: functional residual capacity (FRC)

    Measured: Baseline (day 0)

  75. Plethysmography for lung volumes: functional residual capacity (FRC)

    Measured: 3 months

  76. Plethysmography for lung volumes: functional residual capacity (FRC)

    Measured: 6 months

  77. Plethysmography for lung volumes: functional residual capacity (FRC)

    Measured: 9 months

  78. Plethysmography for lung volumes: functional residual capacity (FRC)

    Measured: 12 months

  79. Plethysmography for lung volumes: total lung capacity (TLC)

    Measured: Baseline (day 0)

  80. Plethysmography for lung volumes: total lung capacity (TLC)

    Measured: 3 months

  81. Plethysmography for lung volumes: total lung capacity (TLC)

    Measured: 6 months

  82. Plethysmography for lung volumes: total lung capacity (TLC)

    Measured: 9 months

  83. Plethysmography for lung volumes: total lung capacity (TLC)

    Measured: 12 months

  84. Plethysmography for lung volumes: RV/TLC

    Measured: Baseline (day 0)

  85. Plethysmography for lung volumes: RV/TLC

    Measured: 3 months

  86. Plethysmography for lung volumes: RV/TLC

    Measured: 6 months

  87. Plethysmography for lung volumes: RV/TLC

    Measured: 9 months

  88. Plethysmography for lung volumes: RV/TLC

    Measured: 12 months

  89. Drug consumption throughout the study.

    Measured: 12 months

  90. The number of adverse events will be recorded throughout the study.

    Measured: 12 months

  91. Episodes of exacerbation throughout the study

    For each exacerbation, the beginning and end dates will be recorded.

    Measured: 12 months

  92. Episodes of hospitalization throughout the study

    For each hospitalization, the beginning and end dates will be recorded.

    Measured: 12 months

  93. 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.

    Measured: 12 months

  94. 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.

    Measured: Baseline (day 0)

  95. 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.

    Measured: 3 months

  96. 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.

    Measured: 6 months

  97. 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.

    Measured: 9 months

  98. 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.

    Measured: 12 months

  99. 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.

    Measured: Baseline (day 0)

  100. 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.

    Measured: 3 months

  101. 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.

    Measured: 6 months

  102. 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.

    Measured: 9 months

  103. 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.

    Measured: 12 months

  104. St-George's Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: Baseline (day 0)

  105. St-George's Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: 3 months

  106. St-George's Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: 6 months

  107. St-George's Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: 9 months

  108. St-George's Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: 12 months

  109. Blood cell differential: neutrophil levels

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

    Measured: Baseline (day 0)

  110. Blood cell differential: eosinophil levels

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

    Measured: Baseline (day 0)

  111. Blood cell differential: neutrophil levels

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

    Measured: 12 months

  112. Blood cell differential: eosinophil levels

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

    Measured: 12 months

  113. Serum Club cell secretory protein

    Measured: Baseline (day 0)

  114. Serum Club cell secretory protein

    Measured: 12 months

  115. Sputum bacteriology

    Measured: Baseline (day 0)

  116. Sputum bacteriology

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start3 Feb 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial comparing outcomes in 2 parallel arms (36 vs 36 patients).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339270
Sponsor's protocol ID
RECHMPL19_0074
Acronym
COPD-CARhE
Status last verified
Sep 2026
First submitted
2 Apr 2020
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithropycin according to symptoms and Azithromycin according to rheology or symptoms in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jérémy Charriot, MD (04 67 33 67 33, j-charriot@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The main outcome measure is the number of exacerbations over the 12 months of follow-up. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04339270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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