Effects of Saxenda (R) on respiratory function in obese patients with chronic obstructive lung disease

Phase 1

• Conditions: Chronic obstructive pulmonary disease in obese subjects; MedDRA version: 20.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-003551-32-DK
• Lead Sponsor: Hospital of South West Jutland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-22
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluated the effect of Liraglutide 3mg on patient reported outcomes and objective measures of COPD;Secondary Objective: NA;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 0, 4, 20, 40 and 44 weeks