Determining the optimal duration of long-term macrolide antibiotics treatment in COPD with a single center randomized controlled study

Defining long-term macrolide maintenance therapy in COPD: a single center randomized controlled trial: - Vasco da Gama

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004178-24-NL

Enrollment

Registered

2020-06-09

Start date

2020-06-13

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease COPD MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 MedDRA version: 21.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855

Interventions

Trade Name: Azitromycine Zithromax Product Name: Azitromycine Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: COPP patients with azithromycin maintenance therapy for at least 12 montsh and who have a stable exacerbation rate (2 or less exacerbations a year). The initial indication for azithromycin maintenance therapy should be frequent exacerbations (>3 exacerbations a year) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Bronchiectasis Asthma Antibiotics and prednisolon treatment because of an exacerbation in the last month prednisolone maintenance more than 5mg a day

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 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; ;Primary end point(s): Time to first exacerbation;Timepoint(s) of evaluation of this end point: end of the study;Main Objective: To assess the time to first exacerbation of COPD, measured from the time of randomization	—

Measure

Time frame

Secondary Objective: 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; ;Primary end point(s): Time to first exacerbation;Timepoint(s) of evaluation of this end point: end of the study;Main Objective: To assess the time to first exacerbation of COPD, measured from the time of randomization

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Secondary

Measure	Time frame
Secondary end point(s): Quality of life Lungfunction parameters Exacerbation frequency Sputum microbiology Systemic inflammation Safety of prolonged azithromycin usage;Timepoint(s) of evaluation of this end point: end of study	—

Countries

Netherlands

Contacts

Public ContactLongresearch astma/COPD

Amphia

Longresearch@amphia.nl310765952383

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026