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Completed

NCT Number: NCT03466021

Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Body Weight Body Weight Changes Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Weight Loss

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of South West Jutland, Esbjerg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any trial-related activities
  • COPD as defined by FEV1/FVC<70% after maximal broncho-dilatation and in accordance with the Gold guidelines 2017 (25)
  • Previous smoking of ≥ 20 pack-years
  • Overweight defined as BMI > 27 kg/m2
  • Age 30 - 75 years
  • Women of childbearing potential must use a safe anti-contraceptive method

Exclusion criteria

  • Chronic treatment with systemic steroids (inhalation steroids allowed)
  • Current smokers
  • Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c ≥ 48mmol/mol
  • Severe hepatic disease (Alanine transferase > 3 x UNL)
  • Severe impaired renal function (eGFR < 30ml/min)
  • Congestive heart disease New York Heart Association (NYHA) class 3-4
  • History of acute or chronic pancreatitis
  • History of cholecystitis or cholecystolithiasis
  • Pregnant or breastfeeding women
  • Known bronchial asthma or interstitial lung disease
  • Family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma
  • Large goiter or plasma-calcitonin > 50ng/ml

Treatment and study plan

liraglutide

Drug

Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.

Other names: Saxenda, NN2211

Placebo

Drug

Matching injection

Primary outcomes

  1. Transition Dyspnea Index (TDI)

    Time frame: 40 weeks

    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

Secondary outcomes

  1. 6 minutes walking test

    Time frame: 44 weeks

    Walking distance during a 6-minutes walking test

  2. Diffusion capacity of the lung for carbon monoxide (DLCO)

    Time frame: 44 weeks

    Pulmonary Diffusion Capacity measured by Carbon Monoxide (CO) diffusion capacity test

  3. FEV1/FVC

    Time frame: 44 weeks

    Forced expiratory volume in first second (FEV1)/forced vital capacity (FVC)

  4. Total lung capacity (TLC)

    Time frame: 44 weeks

    Total lung capacity

  5. Residual volume (RV)

    Time frame: 44 weeks

    Residual volume

  6. CAT-score

    Time frame: 44 weeks

    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

  7. SF-36

    Time frame: 44 weeks

    Short Form (36) Health Survey, which is a Quality of life questionnaire score, subscale scores are calculated according to the SF-36 manual

  8. CRP

    Time frame: 44 weeks

    Inflammation marker, C-reactive protein, higher value indicates more inflammation

  9. IL-6

    Time frame: 44 weeks

    Inflammation marker, Interleukine 6, higher values indicates more inflammation

  10. MCP-1

    Time frame: 44 weeks

    Inflammation marker, Monocyte Chemoattractant Protein-1, higher value indicates more inflammation

  11. Maximal standard uptake value (SUV max)

    Time frame: Twice over 44 weeks

    Maximal standard uptake value as measure by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation

  12. Mean standard uptake value (SUV mean)

    Time frame: Twice over 44 weeks

    Mean standard uptake value as measured by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation

  13. Total lesion glycolysis (TLG)

    Time frame: Twice over 44 weeks

    Total lesion glycolysis as measured by FDG-PET/CT, a higher value indicates more inflammation

  14. Body weight

    Time frame: 44 weeks

    Changes in body weight

  15. Number of COPD exacerbations

    Time frame: 44 weeks

    Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms.

  16. Changes in use of bronchodilator drugs and anti-inflammatory drugs

    Time frame: 44 weeks

    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.

  17. Apnea/hypopnea index (AHI)

    Time frame: Twice during 44 weeks

    Apnea/hypopnea index, higher value indicates more apnea/hypopnea episodes

  18. Oxygen desaturation index (ODI)

    Time frame: Twice during 44 weeks

    Oxygen desaturation index, higher values indicate more episodes of desaturation

  19. Epworth score

    Time frame: Twice during 44 weeks

    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

Sponsors and collaborators

Lead sponsor

Claus Bogh Juhl

Other

Registry information

Official study title

Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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