A study to investigate the effects of Broncho-Vaxom (OM-85 BV) on the immune system in patients with Chronic obstructive pulmonary disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 17.1Level: 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: EUCTR2013-001940-71-GB
• Lead Sponsor: OM Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-22
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <70%
4. Current or ex-smoker, with >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

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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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)<br>- To measure sputum biomarkers, including IL-1b, MPO, IL-8<br>- To measure lower airway bacterial colonisation <br>- To measure lung function by spirometry<br>- To assess symptom scores/Patient reported outcomes including SGRQ, CAT, mMRC<br>- 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:<br>- Change in H influenzae bacteria concentration from baseline to Day 30<br>- Change in S. pneumoniae bacteria concentration from baseline to Day 30;Timepoint(s) of evaluation of this end point: Day 30