Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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