Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 17.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Broncho-Vaxom
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior to any study procedures 2. Males and Females aged =40 3. Confirmed spirometric evidence of mild to very severe COPD (stage I to IV) according to the WHO GOLD criteria; FEV1/FVC 10PYH (a pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked eg. 10PYH is equal to smoking 20 cigarettes per day for 10 years or 40 cigarettes per day for 5 years) 5. Vaccinated against seasonal influenza >7 days prior to enrolment 6. History of Chronic Bronchitis 7. Exacerbator phenotype – defined as 1 or more treated or untreated acute exacerbations of COPD, with infective component based on symptoms recorded on the patient’s diary card in the previous 12 months, appropriately documented in patients’ medical files 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Suffering from asthma 2. Any known neoplasia or malignancy 3. Other significant respiratory disease such as primary bronchiectasis or mucoviscidosis 4. Known chronic systemic infections or inflammatory conditions like Rheumatoid arthritis, Lupus or any other auto-immune disease 5. Previous organ transplantation 6. Myocardial infarction or cerebrovascular accident within the last 6 months prior to study enrolment 7. Suffering from any respiratory infections within 4 weeks prior to study enrolment 8. Any major surgery within the last 3 months prior to study enrolment 9. Treatment with the following medications: a. antibiotics and systemic and oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1, b. oral vaccination with live vaccine within 4 weeks before Visit 1, c. long-term azithromycin therapy within 3 months before Visit 1, d. previous and/or concomitant immunosuppressive or immunostimulating therapy within 3 months before Visit 1 10. Known allergy or previous intolerance to study medication 11. Females who are pregnant or breast feeding 12. Females of childbearing potential unwilling to use sufficiently reliable method of contraception for the period of the clinical trial 13. Unable to follow instructions and unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorders as well as patients unwilling to abide by the requirements of the protocol, i.e. unable to complete a patient diary. 14. Any other clinical conditions, that in the opinion of the investigator, would not allow safe completion of the clinical study 15. Not willing or unable to give written informed consent 16. Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Broncho-Vaxom on the phagocytic ability of monocyte-derived macrophages (MDMs) in patients with COPD;Secondary Objective: - To measure blood biomarkers, including CRP, fibrinogen, IL-6, immunoglobulins (i.e., IgG1, IgG2, IgG3, IgA, IgM) - To measure sputum biomarkers, including IL-1b, MPO, IL-8 - To measure lower airway bacterial colonisation - To measure lung function by spirometry - To assess symptom scores/Patient reported outcomes including SGRQ, CAT, mMRC - To assess safety, including AEs, SAEs, vital signs, physical examinations and laboratory parameters.;Primary end point(s): Change in phagocytic ability of MDMs from baseline to Day 30 (Visit 3) as measured by challenge with fluorescently labelled dead bacteria, including: - Change in H influenzae bacteria concentration from baseline to Day 30 - Change in S. pneumoniae bacteria concentration from baseline to Day 30;Timepoint(s) of evaluation of this end point: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in phagocytic ability of MDMs from baseline to Days 10 (Visit 2) and 60 (Visit 4) 2. Phagocytic ability of MDMs after 10 and 30 days of treatment and after 30 days off treatment (Visit 4; Day 60) 3. Blood biomarker levels, and changes from baseline at all visits: CRP, fibrinogen, IL-6, immunoglobulins (i.e., IgG1, IgG2, IgG3, IgA, IgM) 4. Sputum biomarker levels, and changes from baseline at all visits: IL-1-b, MPO, IL-8 5. Lower airway bacterial colonisation (as measured by qPCR and quantitative culture) – values and change from baseline at all visits 6. Lung function (as measured by spirometry) – values and change from baseline at all visits 7. Patient reported outcomes; CAT scores and change from baseline at all visits, SGRQ scores and change from baseline at Visit 3, mMRC scores 8. Safety, including AEs, SAEs, vital signs, physical examination and laboratory parameters.;Timepoint(s) of evaluation of this end point: 1. Day 10, Day 60 2. Day 10, Day 30, Day 60 3. Day 10, Day 30, Day 60 4. Day 10, Day 30, Day 60 5. Day 10, Day 30, Day 60 6. Day 10, Day 30, Day 60 7. Day 10, Day 30, Day 60 8. Day 10, Day 30, Day 60 | — |
Countries
United Kingdom
Contacts
Public ContactClinical Research Department
OM Pharma SA
Outcome results
None listed