A Phase 3 interventional study of azithromycin and placebo in Cough, Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, sponsored by Isala. Completed at 1 site in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by Isala · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.
This study is a prospective double-centre, double blind randomised trial. Patients > 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained.
Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo.
Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life.
The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients.
Randomisation will take place using a computer allocation program (BAMI-computer)
Azithromycin and placebo will be provided by Teva Pharmaceuticals. Placebo and azithromycin will be identical in appearance and packaging.
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 84 is below the median of 120 across 184 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: azithromycin
Drug: placebo
azithromycin, tablets, during 12 weeks, three times a week, 250mg
Also known as: Zithromax
placebo
Mean change in the Leicester Cough Questionnaire (LCQ) scores.
Time frame: 2 years
Mean change in the SF 36 and SGRQ scores.
Time frame: 2 years
Change in lung function, (FEV1 (L) and FVC (L)).
Time frame: 2 years
Number of exacerbations.
Time frame: 2 years
Adverse reactions.
Time frame: 2 years
Laboratory values: CRP, ASAT, ALAT
Time frame: 2 years
Sputum analysis
Time frame: 2 years
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Isala