Health TrialsbyHealthPanel

Chronic Airway Disease, Mucus Rheology and Exacerbations

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Azithromycin according to symptomsActive comparator 1 intervention
Group B: Azithromycin according to rheologyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)."

Time frame
12 months

Secondary outcomes

1

The number of mild exacerbations throughout follow-up

A mild exacerbation does not require new additional medicine.

Time frame
12 months
2

The number of moderate exacerbations throughout follow-up

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

Time frame
12 months
3

The number of severe exacerbations throughout follow-up

Severe exacerbations require hospitalization.

Time frame
12 months
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Rheonova

Collaborator

Source ClinicalTrials.gov
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