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NCT Number: NCT04339270

Chronic Airway Disease, Mucus Rheology and Exacerbations

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Bordeaux, Bordeaux, France

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithropycin according to symptoms

Drug

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 symptoms

Drug

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.

Primary outcomes

  1. The main outcome measure is the number of exacerbations over the 12 months of follow-up.

    Time frame: 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)."

Secondary outcomes

  1. The number of mild exacerbations throughout follow-up

    Time frame: 12 months

    A mild exacerbation does not require new additional medicine.

  2. The number of moderate exacerbations throughout follow-up

    Time frame: 12 months

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

  3. The number of severe exacerbations throughout follow-up

    Time frame: 12 months

    Severe exacerbations require hospitalization.

  4. COPD Assessment Test (CAT)

    Time frame: Baseline (Day 0)

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

  5. COPD Assessment Test (CAT)

    Time frame: 3 months

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

  6. COPD Assessment Test (CAT)

    Time frame: 6 months

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

  7. COPD Assessment Test (CAT)

    Time frame: 9 months

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

  8. COPD Assessment Test (CAT)

    Time frame: 12 months

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

  9. Sino Nasal Outcome Test 22

    Time frame: 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).

  10. Sino Nasal Outcome Test 22

    Time frame: 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).

  11. Sino Nasal Outcome Test 22

    Time frame: 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).

  12. Sino Nasal Outcome Test 22

    Time frame: 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).

  13. Sino Nasal Outcome Test 22

    Time frame: 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).

  14. Cough and sputum assessment questionnaire (CASA-Q)

    Time frame: 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.

  15. Cough and sputum assessment questionnaire (CASA-Q)

    Time frame: 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.

  16. Cough and sputum assessment questionnaire (CASA-Q)

    Time frame: 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.

  17. Cough and sputum assessment questionnaire (CASA-Q)

    Time frame: 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.

  18. Cough and sputum assessment questionnaire (CASA-Q)

    Time frame: 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.

  19. Visual analogue scale for dyspnea

    Time frame: 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).

  20. Visual analogue scale for dyspnea

    Time frame: 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).

  21. Visual analogue scale for dyspnea

    Time frame: 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).

  22. Visual analogue scale for dyspnea

    Time frame: 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).

  23. Visual analogue scale for dyspnea

    Time frame: 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).

  24. Visual analogue scale for coughing

    Time frame: 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).

  25. Visual analogue scale for coughing

    Time frame: 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).

  26. Visual analogue scale for coughing

    Time frame: 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).

  27. Visual analogue scale for coughing

    Time frame: 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).

  28. Visual analogue scale for coughing

    Time frame: 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).

  29. Visual analogue scale for sputum production

    Time frame: 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).

  30. Visual analogue scale for sputum production

    Time frame: 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).

  31. Visual analogue scale for sputum production

    Time frame: 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).

  32. Visual analogue scale for sputum production

    Time frame: 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).

  33. Visual analogue scale for sputum production

    Time frame: 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).

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

    Time frame: Baseline (Day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (Day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (Day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (Day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

  59. Spirometry: forced vital capacity (FVC)

    Time frame: Baseline (day 0)

  60. Spirometry: forced vital capacity (FVC)

    Time frame: 3 months

  61. Spirometry: forced vital capacity (FVC)

    Time frame: 6 months

  62. Spirometry: forced vital capacity (FVC)

    Time frame: 9 months

  63. Spirometry: forced vital capacity (FVC)

    Time frame: 12 months

  64. Spirometry: FEV1/FVC

    Time frame: Baseline (day 0)

  65. Spirometry: FEV1/FVC

    Time frame: 3 months

  66. Spirometry: FEV1/FVC

    Time frame: 6 months

  67. Spirometry: FEV1/FVC

    Time frame: 9 months

  68. Spirometry: FEV1/FVC

    Time frame: 12 months

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

    Time frame: Baseline (day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

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

    Time frame: Baseline (day 0)

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

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 9 months

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

    Time frame: 12 months

  84. Plethysmography for lung volumes: RV/TLC

    Time frame: Baseline (day 0)

  85. Plethysmography for lung volumes: RV/TLC

    Time frame: 3 months

  86. Plethysmography for lung volumes: RV/TLC

    Time frame: 6 months

  87. Plethysmography for lung volumes: RV/TLC

    Time frame: 9 months

  88. Plethysmography for lung volumes: RV/TLC

    Time frame: 12 months

  89. Drug consumption throughout the study.

    Time frame: 12 months

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

    Time frame: 12 months

  91. Episodes of exacerbation throughout the study

    Time frame: 12 months

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

  92. Episodes of hospitalization throughout the study

    Time frame: 12 months

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

  93. Clinical improvement

    Time frame: 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.

  94. Medical outcomes study 36-Item Short Form Survey (SF-36)

    Time frame: 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.

  95. Medical outcomes study 36-Item Short Form Survey (SF-36)

    Time frame: 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.

  96. Medical outcomes study 36-Item Short Form Survey (SF-36)

    Time frame: 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.

  97. Medical outcomes study 36-Item Short Form Survey (SF-36)

    Time frame: 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.

  98. Medical outcomes study 36-Item Short Form Survey (SF-36)

    Time frame: 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.

  99. EQ-5D-5L

    Time frame: 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.

  100. EQ-5D-5L

    Time frame: 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.

  101. EQ-5D-5L

    Time frame: 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.

  102. EQ-5D-5L

    Time frame: 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.

  103. EQ-5D-5L

    Time frame: 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.

  104. St-George's Respiratory Questionnaire

    Time frame: Baseline (day 0)

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

  105. St-George's Respiratory Questionnaire

    Time frame: 3 months

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

  106. St-George's Respiratory Questionnaire

    Time frame: 6 months

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

  107. St-George's Respiratory Questionnaire

    Time frame: 9 months

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

  108. St-George's Respiratory Questionnaire

    Time frame: 12 months

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

  109. Blood cell differential: neutrophil levels

    Time frame: Baseline (day 0)

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

  110. Blood cell differential: eosinophil levels

    Time frame: Baseline (day 0)

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

  111. Blood cell differential: neutrophil levels

    Time frame: 12 months

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

  112. Blood cell differential: eosinophil levels

    Time frame: 12 months

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

  113. Serum Club cell secretory protein

    Time frame: Baseline (day 0)

  114. Serum Club cell secretory protein

    Time frame: 12 months

  115. Sputum bacteriology

    Time frame: Baseline (day 0)

  116. Sputum bacteriology

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud BOURDIN, MD

CONTACT

[email protected]

04 67 33 67 33

Jérémy Charriot, MD

CONTACT

[email protected]

04 67 33 67 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Rheonova

Registry information

Official study title

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

Acronym: COPD-CARhE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2020
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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