Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

NCT ID: NCT03466021

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-05-31

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.

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Liraglutide

Liraglutide injection 3.0 mg daily

Group Type: ACTIVE_COMPARATOR

Liraglutide

Intervention Type: DRUG

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

Placebo

Placebo, matching injection pen

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching injection

Interventions

Liraglutide

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

Intervention Type: DRUG

Placebo

Matching injection

Intervention Type: DRUG

Other Intervention Names

Saxenda; NN2211

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Claus Bogh Juhl

OTHER

Sponsor Role: lead

Responsible Party

Claus Bogh Juhl

MD. ph.d

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claus B Juhl, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Hospital - University Hospital of Southern Denmark

Locations

Hospital of South West Jutland

Esbjerg, , Denmark

Lillebaelt Hospital

Vejle, , Denmark

Countries

Denmark

References

Dogan ADA, Christensen TQ, Jensen TT, Juhl CB, Hilberg O, Bladbjerg EM, Hess S. FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients. BMC Res Notes. 2024 Jun 20;17(1):170. doi: 10.1186/s13104-024-06820-w.

Reference Type: DERIVED

PMID: 38902794 (View on PubMed)

Other Identifiers

U1111-1188-8695

Identifier Type: -

Identifier Source: org_study_id