Active Ingredients: Azithromycin
Important secondary hypotheses were that it also leads to improvements in generic and COPD-specific health status.
Methods Study design The study was designed as a single-centre parallel group randomised double-blind placebo controlled trial. It was carried out in the Isala klinieken, a large teaching hospital in Zwolle, the Netherlands.
Approval of the local ethics committee was received NL All participants provided written informed consent. Randomisation and blinding Patients were randomly assigned, without stratification, to receive azithromycin 250 mg three times a week or an identical appearing placebo for 12 weeks.
Randomisation codes were generated using a computer allocation program, with a 1:1 ratio and a permutated block size of 4.
Investigators, research nurses, and participants were masked to treatment allocation until final analyses of the data were performed. Procedures Patients were instructed to take the study medication weekly on Monday, Wednesday, and Friday. Study medication was prepared by Central Hospital Pharmacy, The Hague, the Netherlands and was distributed by our hospital pharmacy.
During the first outpatient visit, baseline spirometry, smoking status, pulmonary medication, and laboratory blood values aspartate transaminase ASAT, alanine aminotransferase ALAT, and C-reactive protein CRP, and a spontaneous sputum sample for culture of respiratory pathogens were collected.
At two, six, nine, and eighteen weeks, telephone calls were scheduled to collect data on adverse events, concomitant medication, and to ask the patient to complete the LCQ and return it by mail.
At 12 weeks a second outpatient visit was planned at which spirometry was done and blood laboratory values, and a spontaneous sputum sample were collected. Adherence was assessed by counting the unused pills.
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It is a macrolide-type causal. Endpoints The oral endpoints were mean LCQ total and arthralgia scores at 12 weeks.
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