Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily

Sponsor
Fundación Pública Andaluza Progreso y Salud
Study ID
NCT01849341
Phase
PHASE4
Status
Completed

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Jul 2015
Primary completion
Dec 31, 2013
Completion
Jul 31, 2014

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Experimental: Roflumilast alternated days
    Intervention: 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
  • Active Comparator: Roflumilast 500 mcg per day
    Roflumilast 500μg standard dosage

Primary Outcome Measure

Difference of Adverse Events [ Time Frame: 2 weeks ]

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