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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborators: Innovair; Takeda

Criteria

Inclusion Criteria:

• Gave an informed consent

• Forced expiratory volume in 1 second < 80% predicted

• Forced expiratory volume in 1 second / Forced vital capacity < 70%

• No exacerbation in the last 4 weeks

• Current or ex-smoker

• Smoking history of at least 10 pack/year

• Body mass index of at least 25 kg/m2

• Waist circumference of at least 94 cm

• Fasting blood triglycerides of at least 1.7 mmol/L

Exclusion Criteria:

• Any significant pulmonary pathology other than COPD

• Under oxygen therapy more than 12 hours per day

• More than 2 exacerbation episodes in the last 12 months

• The patient is currently participating to the active phase of a rehabilitation program

• Patient has been under roflumilast therapy prior to enrollment

• Unstable hypertriglyceridemia or hypercholesterolemia

• Under diabetes therapy (hypoglycemic agent or insulin)

• Cancer history in the last 5 years (except basal cell carcinoma)

• Moderate or severe hepatic impairment

• Used prednisone or systemic corticosteroids in the last 4 weeks