Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Transition Dyspnea Index (TDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Liraglutide
Liraglutide injection 3.0 mg daily
干预措施: Liraglutide (Drug)
Placebo
Placebo, matching injection pen
干预措施: Placebo (Drug)
结局指标
主要结局
Transition Dyspnea Index (TDI)
时间窗: 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
次要结局
- 6 minutes walking test(44 weeks)
- Diffusion capacity of the lung for carbon monoxide (DLCO)(44 weeks)
- Oxygen desaturation index (ODI)(Twice during 44 weeks)
- Total lesion glycolysis (TLG)(Twice over 44 weeks)
- Total lung capacity (TLC)(44 weeks)
- Residual volume (RV)(44 weeks)
- CAT-score(44 weeks)
- CRP(44 weeks)
- Mean standard uptake value (SUV mean)(Twice over 44 weeks)
- Body weight(44 weeks)
- FEV1/FVC(44 weeks)
- SF-36(44 weeks)
- IL-6(44 weeks)
- MCP-1(44 weeks)
- Maximal standard uptake value (SUV max)(Twice over 44 weeks)
- Number of COPD exacerbations(44 weeks)
- Epworth score(Twice during 44 weeks)
- Changes in use of bronchodilator drugs and anti-inflammatory drugs(44 weeks)
- Apnea/hypopnea index (AHI)(Twice during 44 weeks)
研究者
Claus Bogh Juhl
MD. ph.d
Esbjerg Hospital - University Hospital of Southern Denmark