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Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily — ROFLU2011  

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
Clinical Trial Phase III Blind, Parallel Group to Analyze Differences in the Safety of Roflumilast Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01849341
Study type Interventional
Source Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Contact
Status Completed
Phase Phase 4
Start date July 2012
Completion date July 2014
View Details
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