Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Claus Bogh Juhl
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities

2. COPD as defined by FEV1/FVC<70% after maximal broncho-dilatation and in accordance with the Gold guidelines 2017 (25)

3. Previous smoking of ≥ 20 pack-years

4. Overweight defined as BMI > 27 kg/m2

5. Age 30 - 75 years

6. Women of childbearing potential must use a safe anti-contraceptive method

Exclusion Criteria:

1. Chronic treatment with systemic steroids (inhalation steroids allowed)

2. Current smokers

3. Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c ≥ 48mmol/mol

4. Severe hepatic disease (Alanine transferase > 3 x UNL)

5. Severe impaired renal function (eGFR < 30ml/min)

6. Congestive heart disease New York Heart Association (NYHA) class 3-4

7. History of acute or chronic pancreatitis

8. History of cholecystitis or cholecystolithiasis

9. Pregnant or breastfeeding women

10. Known bronchial asthma or interstitial lung disease

11. Family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma

12. Large goiter or plasma-calcitonin > 50ng/ml