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

NCT01849341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-07-08

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Roflumilast alternated days

500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks

DRUG

Roflumilast 500 mcg per day

Sponsors & Collaborators

  • Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Teodoro Montemayor Rubio, M.D. Ph D · Hospital Universitario Virgen Macarena

  • Ruth Ayerbe, M.D · Complejo Hospitalario de Especialidades Juan Ramón Jimenez

  • Gregorio Soto, M.D. · Hospital de Jerez

  • Francisco L Muñoz, M.D. · Hospital Universitario Reina Sofía

  • Concepción Morales, M.D. · H.U. Virgen de las Nieves

  • José L de la Cruz, M.D. · Complejo Hospitalario Carlos Haya

  • Cristina García, M.D. · Hospital Universitario de Puerto Real

  • Bernardino Alcázar, M.D. · HAR de Loja

  • Rosa Vazquez, M.D. · Hospital Infanta Elena

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-12-31
Completion
2014-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01849341 on ClinicalTrials.gov