Defining macrolide maintenance therapy in COPD with a single center randomized controlled trial

M.J.J.H. Grootenboers0 个研究点目标入组 64 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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

•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

发起方

M.J.J.H. Grootenboers