Chronic obstructive pulmonary disease (COPD) of different severity MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Trade Name: ERDOTIN
Product Name: Erdosteine
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of adminis
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. COPD patients with FEV1/FVC 10 pack years) and ex-smokers 3. Patients will be allowed to use their current bronchodilators (anticholinergics and long-acting ß2-agonists) and continued on their current dose of inhaled corticosteroids 4. Aged 38 - 80 years inclusive 5. Body mass index within the range 19-32 kg/m2 inclusive 6. FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. For female subjects of childbearing potential: pregnant or breast-feeding women, or lack of efficient contraception (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature) 2. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study 3. The subject regularly, or on average, drinks more than 21 units of alcohol per week 4. The subject has received antibiotics and/or oral steroids within 2 months of study entry 5. The subject has been hospitalised for a COPD exacerbation within 2 months of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Erdosteine has anti-oxidative placebo-different effect that can be demonstrated by measuring the proposed sputum biomarkers ; Secondary Objective: To demonstrate that anti-oxidative effect of Erdosteine is also reflected by the improvement of phagocytotic activity of peripheral blood mononuclear cells (PBMC), oxidative biomarkers in exhaled breath and condensate, peripheral blood, lung function, symptoms and quality of life Secondary outcome variables: 1. exhaled breath condensate (8-isoprostane, LTB4) 2. exhaled multiple exhalation flow (MEFTeNO, Cal, JNO and DNO) 3. peripheral blood (8-isoprostanes; GSH; LTB4; total radical trapping antioxidant potential (TRAP) and Trolox equivalent antioxidant capacity (TEAC) 4. spirometry: FEV1, FVC, FEV1/FVC 5. Borg dyspnoea score 6. questionnaires (Hospital Anxiety and Depression Scale, St. George's Respiratory Questionnaire) 7. fat free mass measurements 8. pedometer measurements ;Primary end point(s): 8-isoprostanes and LTB4 in induced sputum as markers of oxidative stress | — |
Countries
United Kingdom
Outcome results
None listed