Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease

Sponsor
Laval University
Study ID
NCT01701934
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    500 mcg, oral, once daily for 6 months
  • Placebo — DRUG
    One placebo pill daily, for 6 months

Study Details

The purpose of this study is to determine whether roflumilast can improve metabolic profile and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).

Key Dates

Start date
Feb 28, 2013
Status verified
Nov 2014
Primary completion
Oct 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    Roflumilast 500 mcg, once daily for 6 months
  • Placebo Comparator: Placebo pill
    Placebo pill, once daily for 6 months

Primary Outcome Measure

Change in intrabdominal adiposity [ Time Frame: At baseline and 6 months later ]

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