None listed
Conditions
Brief summary
Bronchiectasis is a troublesome disease characterised by productive cough, airway inflammation, and repeated respiratory infections. There are currently no specific treatments licensed for use in bronchiectasis worldwide. Oral bacterial vaccines have been shown to regulate the immune system and enhance the killing of important respiratory bacteria. This is a single center, double-blinded randomised, placebo-controlled study in adult patients with non-cystic fibrosis bronchiectasis. The main aim of this study is to assess whether Bactek-O (a sublingual bacterial vaccine) can reduce inflammation in the lungs. We will also assess for similar changes in the bloodstream and whether the types of bacteria present in the lungs change following use of Bactek-O. This pilot study will provide important information for the development of a larger study to assess whether Bactek-O treatment can prevent flare-ups (exacerbations) in patients with bronchiectasis. Participants will attend 5 study visits (one of which is a screening visit) over this 6 month study where they will have their health-assessed (vital signs, lung function, sputum, nasal swabs and blood samples taken), complete questionnaires and study diaries.
Interventions
Single centre, double-blinded, randomised, placebo-controlled study in patients with non-cystic fibrosis bronchiectasis. Patients aged over 18 years with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT scan.
Bactek-O is a commercially available polyvalent bacterial preparation (Immunotek Laboratories, Madrid, Spain). It is administered in liquid form as a spray, sublingually. It contains different species of inactivated bacteria that are frequently present in the respiratory
Single centre, double-blinded, randomised, placebo-controlled study in patients with non-cystic fibrosis bronchiectasis. Patients aged over 18 years with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT scan. Bactek-O is a commercially available polyvalent bacterial preparation (Immunotek Laboratories, Madrid, Spain). It is administered in liquid form as a spray, sublingually. It contains different species of inactivated bacteria that are frequently present in the respiratory tract: Streptococcus pyogenes (15%), Moraxella catarrhalis (15%), Haemophilus influenzae (35%), Streptococcus pneumoniae (35%). The other excipients are glycerol, pineapple essence to improve taste, sodium chloride and water for injection Bactek-O vaccine and a placebo will be identically packaged and delivered sublingually. Eligible subjects will be randomised to Bactek-O vaccine or placebo with the following regime: day 1, one sublingual spray and thereafter, up to day 180, two sublingual sprays daily. The total duration of treatment is therefore 6 months. The dose is 2 x 100 µL sprays. In terms of active ingredients, there is 10^9 bacteria/mL so each spray would have 10^8 b/mL. Adherence will be monitored and measured by keeping and reviewing the bottles both through visual inspection and weight assessment. Patient's adherence with the proper use of the study drug or placebo will be assessed at visits 3 and 4, and patients will be reminded to bring all study medication pack(s) (used or unused) and completed diaries to these visits
Sponsors
Health Research Council of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or over. • Able to provide written informed consent. • Able to provide spontaneous sputum sample at visit 2 (week 0). • High-resolution CT scan (HRCT) diagnosis of bronchiectasis; CT scan performed within the past 5 years • Clinically stable during baseline period, which is 4 weeks prior to randomisation (as defined by the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone and stable spirometry). • History of at least one pulmonary exacerbation requiring antibiotic treatment in the past 12 months. Patients with asthma and COPD will be included if the primary diagnosis is bronchiectasis.
Exclusion criteria
Oral or intravenous antibiotic treatment (including macrolides) within 4 weeks prior to commencing study drug. • Patients taking continuous oral corticosteroids (> 6 weeks) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide). • Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic or steroid treatment within 4 weeks prior to commencing study drug. • Patients with a history of non-adherence with medications. • Patients with significant medical conditions other than bronchiectasis. o A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study. • Patients with cystic fibrosis. • Patients with hypo-gammaglobulinaemia. • Patients with primary ciliary dyskinesia. • Patients with allergic bronchopulmonary aspergillosis (total IgE >420 IU/mL and aspergillus specific IgE level of +3 or +4, and proximal bronchiectasis on HRCT). • Patients with evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is greater than or equal to 20% within 2 years judged by the treating physician (patients with basal cell carcinoma and squamous cell carcinoma are allowed). Patients who have undergone resection, radiation therapy or chemotherapy within 6 months prior to the first dose of the study drug or the expectation that such treatment will be required at any time during the study will also be excluded. • Pregnant or lactating women. • Participation in a separate clinical or device trial within 4 weeks prior to screening. • Allergy to any of the components of Bactek-O • Patients with chronic bacterial infection of Pseudomonas aeriginosa. This is defined by positive culture from standard microbiology from the lower airways of the same Pseudomonas aeriginosa on two or more occasions at least three months apart over one year in stable state.
Outcome results
None listed