E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease in obese subjects |
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E.1.1.1 | Medical condition in easily understood language |
Chronic obstructive pulmonary disease in obese subjects |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009033 |
E.1.2 | Term | Chronic obstructive pulmonary disease |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the study is to evaluated the effect of Liraglutide 3mg on patient reported outcomes and objective measures of COPD |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0, 4, 20, 40 and 44 weeks |
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E.5.2 | Secondary end point(s) |
1. walking distance during a 6-minutes walking test 2. pulmonary diffusion capacity as measured by carbon monoxid (CO) diffusion test providing a measure of pulmonary CO diffusion capacity and CO diffusion capacity divided by alveolar volume (DLCO/VA) 3. forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) as measured by spirometry total lung capacity (TLC), residual volume (RV) and DLCO/VA 4. COPD Assessment Test (CAT)-score 5. SF-36 quality of life questionnaire score 6. markers of inflammation: CRP, IL-6 and MCP-1 7. pulmonary inflammation as assessed by PET/CT using semiquantitative and quantitative measures of radioactive distribution: SUVmax, SUVmean, TLG 8. body weight 9. Number of COPD exacerbations as defined by: Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms. 10. Changes in use of bronchodilator drugs and anti-inflammatory drugs as 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. 11. Apnea/hypopnea index 12. Oxygen desaturation index (ODI) 13. Epworth score |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0, 4, 20, 40 and 44 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be prematurely stopped if serious adverse events compromising the safety of the study population is detected |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |