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| Name | Class |
|---|---|
| Rheonova | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin according to symptoms | Active Comparator | Patients randomized to this arm will be prescribed azithromycin in function of their symptoms. |
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| Azithromycin according to rheology | Experimental | Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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)." | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of mild exacerbations throughout follow-up | A mild exacerbation does not require new additional medicine. | 12 months |
| The number of moderate exacerbations throughout follow-up | Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jérémy Charriot, MD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Bordeaux | Recruiting | Bordeaux | France |
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).
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As close to "real time" as possible, the following supporting information will be made public:
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.
The conditions under which members of the public will be granted access to datasets are:
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomized controlled trial comparing outcomes in 2 parallel arms (36 vs 36 patients).
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CASA-Q scoring is performed by the patient and then sealed away from investigator-view. Similarly, mucus rheology results are blinded. The patient does not know what arm he/she is in, as so does not know exactly why the prescription was made or not.
Similarly, investigators/outcome assessors are blinded to both CASA-Q scores and sputum rheology. The prescription strategy is determined according to an algorithm, and investigators/outcome assessors do not know what arm the patient is in nor exactly why a prescription was made or not.
|
| 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.
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| 12 months |
| The number of severe exacerbations throughout follow-up | Severe exacerbations require hospitalization. | 12 months |
| COPD Assessment Test (CAT) | Scores range from 0-40 with higher scores indicative of greater COPD impact on health status. | Baseline (Day 0) |
| COPD Assessment Test (CAT) | Scores range from 0-40 with higher scores indicative of greater COPD impact on health status. | 3 months |
| COPD Assessment Test (CAT) | Scores range from 0-40 with higher scores indicative of greater COPD impact on health status. | 6 months |
| COPD Assessment Test (CAT) | Scores range from 0-40 with higher scores indicative of greater COPD impact on health status. | 9 months |
| COPD Assessment Test (CAT) | Scores range from 0-40 with higher scores indicative of greater COPD impact on health status. | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 12 months |
| Rheology: modulus of elasticity of mucus (G ') | Baseline (Day 0) |
| Rheology: modulus of elasticity of mucus (G ') | 3 months |
| Rheology: modulus of elasticity of mucus (G ') | 6 months |
| Rheology: modulus of elasticity of mucus (G ') | 9 months |
| Rheology: modulus of elasticity of mucus (G ') | 12 months |
| Rheology: the viscous module (G '') | Baseline (Day 0) |
| Rheology: the viscous module (G '') | 3 months |
| Rheology: the viscous module (G '') | 6 months |
| Rheology: the viscous module (G '') | 9 months |
| Rheology: the viscous module (G '') | 12 months |
| Rheology: The ratio G '' / G ' | Baseline (Day 0) |
| Rheology: The ratio G '' / G ' | 3 months |
| Rheology: The ratio G '' / G ' | 6 months |
| Rheology: The ratio G '' / G ' | 9 months |
| Rheology: The ratio G '' / G ' | 12 months |
| Rheology: the critical constraint (tau-C). | Baseline (Day 0) |
| Rheology: the critical constraint (tau-C). | 3 months |
| Rheology: the critical constraint (tau-C). | 6 months |
| Rheology: the critical constraint (tau-C). | 9 months |
| Rheology: the critical constraint (tau-C). | 12 months |
| Spirometry: forced expiratory volume in 1 minute (FEV1) | Baseline (day 0) |
| Spirometry: forced expiratory volume in 1 minute (FEV1) | 3 months |
| Spirometry: forced expiratory volume in 1 minute (FEV1) | 6 months |
| Spirometry: forced expiratory volume in 1 minute (FEV1) | 9 months |
| Spirometry: forced expiratory volume in 1 minute (FEV1) | 12 months |
| Spirometry: forced vital capacity (FVC) | Baseline (day 0) |
| Spirometry: forced vital capacity (FVC) | 3 months |
| Spirometry: forced vital capacity (FVC) | 6 months |
| Spirometry: forced vital capacity (FVC) | 9 months |
| Spirometry: forced vital capacity (FVC) | 12 months |
| Spirometry: FEV1/FVC | Baseline (day 0) |
| Spirometry: FEV1/FVC | 3 months |
| Spirometry: FEV1/FVC | 6 months |
| Spirometry: FEV1/FVC | 9 months |
| Spirometry: FEV1/FVC | 12 months |
| Plethysmography for lung volumes: residual volume (RV) | Baseline (day 0) |
| Plethysmography for lung volumes: residual volume (RV) | 3 months |
| Plethysmography for lung volumes: residual volume (RV) | 6 months |
| Plethysmography for lung volumes: residual volume (RV) | 9 months |
| Plethysmography for lung volumes: residual volume (RV) | 12 months |
| Plethysmography for lung volumes: functional residual capacity (FRC) | Baseline (day 0) |
| Plethysmography for lung volumes: functional residual capacity (FRC) | 3 months |
| Plethysmography for lung volumes: functional residual capacity (FRC) | 6 months |
| Plethysmography for lung volumes: functional residual capacity (FRC) | 9 months |
| Plethysmography for lung volumes: functional residual capacity (FRC) | 12 months |
| Plethysmography for lung volumes: total lung capacity (TLC) | Baseline (day 0) |
| Plethysmography for lung volumes: total lung capacity (TLC) | 3 months |
| Plethysmography for lung volumes: total lung capacity (TLC) | 6 months |
| Plethysmography for lung volumes: total lung capacity (TLC) | 9 months |
| Plethysmography for lung volumes: total lung capacity (TLC) | 12 months |
| Plethysmography for lung volumes: RV/TLC | Baseline (day 0) |
| Plethysmography for lung volumes: RV/TLC | 3 months |
| Plethysmography for lung volumes: RV/TLC | 6 months |
| Plethysmography for lung volumes: RV/TLC | 9 months |
| Plethysmography for lung volumes: RV/TLC | 12 months |
| Drug consumption throughout the study. | 12 months |
| The number of adverse events will be recorded throughout the study. | 12 months |
| Episodes of exacerbation throughout the study | For each exacerbation, the beginning and end dates will be recorded. | 12 months |
| Episodes of hospitalization throughout the study | For each hospitalization, the beginning and end dates will be recorded. | 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:
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months |
| St-George's Respiratory Questionnaire | Scores range from 0 to 100, with higher scores indicating more limitations. | Baseline (day 0) |
| St-George's Respiratory Questionnaire | Scores range from 0 to 100, with higher scores indicating more limitations. | 3 months |
| St-George's Respiratory Questionnaire | Scores range from 0 to 100, with higher scores indicating more limitations. | 6 months |
| St-George's Respiratory Questionnaire | Scores range from 0 to 100, with higher scores indicating more limitations. | 9 months |
| St-George's Respiratory Questionnaire | Scores range from 0 to 100, with higher scores indicating more limitations. | 12 months |
| Blood cell differential: neutrophil levels | A complete blood cell differential will be taken, including neutrophilia and eosinophilia. | Baseline (day 0) |
| Blood cell differential: eosinophil levels | A complete blood cell differential will be taken, including neutrophilia and eosinophilia. | Baseline (day 0) |
| Blood cell differential: neutrophil levels | A complete blood cell differential will be taken, including neutrophilia and eosinophilia. | 12 months |
| Blood cell differential: eosinophil levels | A complete blood cell differential will be taken, including neutrophilia and eosinophilia. | 12 months |
| Serum Club cell secretory protein | Baseline (day 0) |
| Serum Club cell secretory protein | 12 months |
| Sputum bacteriology | Baseline (day 0) |
| Sputum bacteriology | 12 months |
| University Hospitals of Montpellier | Recruiting | Montpellier | 34925 | France |
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| University Hospitals of Toulouse | Recruiting | Toulouse | France |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |