Effects of Liraglutide in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      COPD is a common disease characterized by pulmonary inflammation, reduced pulmonary capacity,
      reduced physical activity and quality of life. Obesity is likewise a common disease
      characterized by inflammation, reduced physical activity and quality of life. Targeting both
      obesity and inflammation may turn out beneficial for patients with COPD and obesity, and this
      study explore the possibility to reverse a vicious cycle of COPD, lack of physical activity
      and obesity. The primary objective of the study is to evaluate the effect of Liraglutide 3mg
      in patients with COPD on patient reported outcomes as measured by the Transition Dyspnea
      Index. The hypothesis is that Liraglutide 3mg exerts beneficial effects on measures of
      pulmonary function and quality of life in overweight patients with COPD by reducing body
      weight and reducing inflammatory activity.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.; Matching injection
Other intervention name(s): Saxenda; NN2211
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, placebo-controlled, double-blinded, parallel group and two-center trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GLP-1 receptor agonist; Chronic obstructive pulmonary disease; FDG/PET-CT; inflammation; weightloss; quality of life