Trial · Interventional

CompletedPhase 4Registry data

Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

NCTNCT03466021Other idU1111-1188-8695

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 40 participants (actual)
Sponsor: Claus Bogh Juhl · Other
Design: Randomized · Double masking
Countries: 1 country
Denmark
Start: 1 Jan 2018
Primary completion: 31 May 2020
Completion: 31 May 2020
First posted: 15 Mar 2018
Last update posted: 16 Mar 2021
Conditions: Pulmonary Disease, Chronic Obstructive

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018201920202021

Ph 4
Effects of Liraglutide in Chronic Obstructive Pulmonary Disease
NCT03466021
1 Jan 2018 to 31 May 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
PlaceboDrug

Arms2

Active comparator
Liraglutide
Liraglutide injection 3.0 mg daily
Placebo comparator
Placebo
Placebo, matching injection pen

Primary outcomes1

Outcomes the sponsor listed as primary.

Transition Dyspnea Index (TDI)
Time frame · 40 weeks
Registry description
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(19)

6 minutes walking test
Time frame · 44 weeks
Registry description
Walking distance during a 6-minutes walking test
Diffusion capacity of the lung for carbon monoxide (DLCO)
Time frame · 44 weeks
Registry description
Pulmonary Diffusion Capacity measured by Carbon Monoxide (CO) diffusion capacity test
FEV1/FVC
Time frame · 44 weeks
Registry description
Forced expiratory volume in first second (FEV1)/forced vital capacity (FVC)
Total lung capacity (TLC)
Time frame · 44 weeks
Registry description
Total lung capacity
Residual volume (RV)
Time frame · 44 weeks
Registry description
Residual volume
CAT-score
Time frame · 44 weeks
Registry description
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
SF-36
Time frame · 44 weeks
Registry description
Short Form (36) Health Survey, which is a Quality of life questionnaire score, subscale scores are calculated according to the SF-36 manual
CRP
Time frame · 44 weeks
Registry description
Inflammation marker, C-reactive protein, higher value indicates more inflammation
IL-6
Time frame · 44 weeks
Registry description
Inflammation marker, Interleukine 6, higher values indicates more inflammation
MCP-1
Time frame · 44 weeks
Registry description
Inflammation marker, Monocyte Chemoattractant Protein-1, higher value indicates more inflammation
Maximal standard uptake value (SUV max)
Time frame · Twice over 44 weeks
Registry description
Maximal standard uptake value as measure by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Mean standard uptake value (SUV mean)
Time frame · Twice over 44 weeks
Registry description
Mean standard uptake value as measured by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Total lesion glycolysis (TLG)
Time frame · Twice over 44 weeks
Registry description
Total lesion glycolysis as measured by FDG-PET/CT, a higher value indicates more inflammation
Body weight
Time frame · 44 weeks
Registry description
Changes in body weight
Number of COPD exacerbations
Time frame · 44 weeks
Registry description
Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms.
Changes in use of bronchodilator drugs and anti-inflammatory drugs
Time frame · 44 weeks
Registry description
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.
Apnea/hypopnea index (AHI)
Time frame · Twice during 44 weeks
Registry description
Apnea/hypopnea index, higher value indicates more apnea/hypopnea episodes
Oxygen desaturation index (ODI)
Time frame · Twice during 44 weeks
Registry description
Oxygen desaturation index, higher values indicate more episodes of desaturation
Epworth score
Time frame · Twice during 44 weeks
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

3 results

FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients.

Dogan et al. 2024BMC research notescited by 1

PMID 38902794PMC11188287DOI 10.1186/s13104-024-06820-wPUB-38902794

CC BY3 results

Download PDF See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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