Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

Sponsor
Claus Bogh Juhl
Study ID
NCT03466021
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Liraglutide — DRUG
    Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.
  • Placebo — DRUG
    Matching injection

Study Details

The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded, parallel group two-center trial. Forty patients are recruited among the outpatients of the chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and Lillebælt Hospital according to the inclusion and exclusion criteria. The patients are randomized to receive liraglutide 3 mg per day (initial dose 0.6 mg, increasing by 0.6 mg weekly until 3 mg is reached) or placebo. At baseline, after four weeks (assessment of the acute effect of liraglutide), 20 weeks, and 40 weeks (assessment of the combined effect of liraglutide and weight loss) and at week 44 (assessment of the weight-loss after discontinuation of liraglutide) the patients are assessed by physical examination, carbon monoxide (CO) diffusion test, pulmonary function test, biomarkers of inflammation (CRP, interleucine-6 (IL-6), monocyte chemitactic protein-1 (MCP-1)), Fluorodeoxyglucose (FDG)/PET-CT scan of the lungs, 6-minute walking test, respiratory polygraphy and validated questionnaires including basic dyspnea index, transition dyspnea index, COPD Assessment Test (CAT)-score, short-form-36 (SF-36) and Epworth Sleepiness Score.

Key Dates

Start date
Jan 1, 2018
Status verified
Mar 2021
Primary completion
May 31, 2020
Completion
May 31, 2020

Study Design

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

Arms

  • Active Comparator: Liraglutide
    Liraglutide injection 3.0 mg daily
  • Placebo Comparator: Placebo
    Placebo, matching injection pen

Primary Outcome Measure

Transition Dyspnea Index (TDI) [ Time Frame: 40 weeks ]

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