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Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03466021
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Claus Bogh Juhl, Hospital of South West Jutland

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Liraglutide Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : February 10, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide
Liraglutide injection 3.0 mg daily
Drug: Liraglutide
Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.
Other Names:
  • Saxenda
  • NN2211

Placebo Comparator: Placebo
Placebo, matching injection pen
Drug: Placebo
Matching injection




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466021


Contacts
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Contact: Ayse Dudu Altintas Dogan, MD + 45 22 71 50 90 ayse.dudu.altintas.dogan@rsyd.dk
Contact: Claus Bogh Juhl, MD, PhD +45 60 86 71 72 claus.bogh.juhl@rsyd.dk

Locations
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Denmark
Hospital of South West Jutland Recruiting
Esbjerg, Denmark, 6700
Contact: Claus B Juhl, MD, PhD    +4560867172    claus.bogh.juhl@rsyd.dk   
Lillebaelt Hospital Recruiting
Vejle, Denmark, 7100
Contact: Ole Hilberg, MD    79406321 ext 45    ole.hilberg@rsyd.dk   
Sponsors and Collaborators
Claus Bogh Juhl
Investigators
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Principal Investigator: Claus B Juhl, MD PhD Hospital of South West Jutland

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Responsible Party: Claus Bogh Juhl, MD. ph.d, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT03466021     History of Changes
Other Study ID Numbers: U1111-1188-8695
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claus Bogh Juhl, Hospital of South West Jutland:
GLP-1 receptor agonist
Chronic obstructive pulmonary disease
FDG/PET-CT
inflammation
weightloss
quality of life

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists