Bactek­O Sublingual Vaccine Treatment in Bronchiectasis - A Pilot Study

Phase 2

Completed

• Conditions: on-cystic fibrosis bronchiectasis; Non-cystic fibrosis bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12618001171202
• Lead Sponsor: Health Research Council of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-16
• Study Completion: 2020-03-10
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sputum procalcitonin[Comparison between baseline and 6 months]