COPD
Conditions
Interventions
withdrawal of azithromycin macrolide treatment
Sponsors
M.J.J.H. Grootenboers
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of COPD according to GOLD 2019 definition Exacerbation > 28 days before inclusion Age = 18 years Azithromycin maintenance therapy for at least one year preceding the start of the trial and initially started because of frequent exacerbations (=3 a year) Clinical stable COPD with azithromycin maintenance, determined as 2 or less exacerbations during the year before randomization Informed consent
Exclusion criteria
Exclusion criteria: Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study Addition of inhalation steroids to the patient's therapy regimen, <28 days before entering the study. Pregnant or lactating women. Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal). Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing. Presence of a malignancy, which is clinically active. Bronchiectasis. Heart failure. Use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ·To assess the time to first exacerbation of COPD, measured from the time of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the improvement of quality of life by Saint George’s Respiratory Questionnaire; To evaluate pulmonary function (FEV1) To evaluate the frequency of exacerbation requiring an intervention with systemic corticosteroids and antibiotics (oral/intravenous [i.v.]) in subjects with COPD. To assess the microbiology of sputum production To assess the safety and tolerability of long term azithromycin To assess the inflammatory response measured by the following inflammatory markers: high-sensitivity C-reactive protein, the erythrocyte sedimentation rate, polymorphonuclear leukocytes, neutrophils; eosinophils; interleukin-6, interleukin-8, and myeloperoxidase; | — |
Contacts
Public ContactSander Talman
Amphia
Outcome results
None listed