Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into
2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention
group was based on the administration of roflumilast 500 mcg per day on alternate days
(roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the
treatment according to the standard dosage (roflumilast 500μg od).
The patient monitoring will be done by one of the sub-investigators fully independent team
that started the medication keeping the pattern masking by single blind, and since it aims to
assess the frequency of adverse events (AEs) in both groups were collected systematically
different AEs and their characteristics at 15 days (V1), and from that moment a month (V2)
and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities,
home treatment, anxiety and depression and quality of life).
The purpose of this study is to assess whether the administration of roflumilast by a gradual
pattern varies the incidence of discontinuations due to adverse events when compared with the
usual dosage.