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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.
Matching injection
Hospital of South West Jutland
Esbjerg, Denmark
Lillebaelt Hospital
Vejle, Denmark
Transition Dyspnea Index (TDI)
The primary objective is to evaluate the effect of Liraglutide 3mg on Transition Dyspnea Index (TDI) after 40 weeks of treatment in subjects with COPD and overweight (BMI\>27 kg/m2). A positive value indicates less dyspnea during specified activities
Time frame: 40 weeks
6 minutes walking test
Walking distance during a 6-minutes walking test
Time frame: 44 weeks
Diffusion capacity of the lung for carbon monoxide (DLCO)
Pulmonary Diffusion Capacity measured by Carbon Monoxide (CO) diffusion capacity test
Time frame: 44 weeks
FEV1/FVC
Forced expiratory volume in first second (FEV1)/forced vital capacity (FVC)
Time frame: 44 weeks
Total lung capacity (TLC)
Total lung capacity
Time frame: 44 weeks
Residual volume (RV)
Residual volume
Time frame: 44 weeks
CAT-score
Chronic Obstructive Pulmonary Disease assessment test, a measure of COPD impact on every day life, total score ranges 0-25, a higher score indicates more symptoms
Time frame: 44 weeks
SF-36
Short Form (36) Health Survey, which is a Quality of life questionnaire score, subscale scores are calculated according to the SF-36 manual
Time frame: 44 weeks
CRP
Inflammation marker, C-reactive protein, higher value indicates more inflammation
Time frame: 44 weeks
IL-6
Inflammation marker, Interleukine 6, higher values indicates more inflammation
Time frame: 44 weeks
MCP-1
Inflammation marker, Monocyte Chemoattractant Protein-1, higher value indicates more inflammation
Time frame: 44 weeks
Maximal standard uptake value (SUV max)
Maximal standard uptake value as measure by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Time frame: Twice over 44 weeks
Mean standard uptake value (SUV mean)
Mean standard uptake value as measured by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Time frame: Twice over 44 weeks
Total lesion glycolysis (TLG)
Total lesion glycolysis as measured by FDG-PET/CT, a higher value indicates more inflammation
Time frame: Twice over 44 weeks
Body weight
Changes in body weight
Time frame: 44 weeks
Number of COPD exacerbations
Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms.
Time frame: 44 weeks
Changes in use of bronchodilator drugs and anti-inflammatory drugs
Defined by an increase in beta2agonists of more than 20 % per week and a change of more than 20 % of dose of anti-inflammatory drugs respectively.
Time frame: 44 weeks
Apnea/hypopnea index (AHI)
Apnea/hypopnea index, higher value indicates more apnea/hypopnea episodes
Time frame: Twice during 44 weeks
Oxygen desaturation index (ODI)
Oxygen desaturation index, higher values indicate more episodes of desaturation
Time frame: Twice during 44 weeks
Epworth score
Epworth sleepiness scale questionnaire, total score is calculated, 0-9: Normal, 10-15: mild to moderate sleep apnea, 16 or more indicate severe sleep apnea
Time frame: Twice during 44 weeks
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