Vasco da Gama

Conditions: COPD

Registration Number: NL-OMON24560

Lead Sponsor: M.J.J.H. Grootenboers

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 64

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
·To assess the time to first exacerbation of COPD, measured from the time of randomization

Secondary Outcome Measures

Name	Time	Method
<br>To evaluate the improvement of quality of life by Saint George’s Respiratory Questionnaire; <br>To evaluate pulmonary function (FEV1) <br>To evaluate the frequency of exacerbation requiring an intervention with systemic corticosteroids and antibiotics (oral/intravenous [i.v.]) in subjects with COPD. <br>To assess the microbiology of sputum production<br>To assess the safety and tolerability of long term azithromycin<br>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;<br>