None listed
Conditions
Brief summary
Bronchiectasis is a chronic, debilitating disease characterised by productive cough, neutrophilic inflammation, bacterial colonisation, and repeated respiratory infections requiring antibiotics. New and innovative approaches to the treatment of airway inflammation and infection are needed. Nicotinamide, the amide derivative of vitamin B3, has anti-inflammatory and anti-oxidant effects, and has recently been shown to boost innate immunity and enhance the killing of bacteria. Several feasibility issues need to be clarified prior to undertaking a full, randomised, placebo-controlled trial of nicotinamide in patients with bronchiectasis. These include determining the effects of high dose nicotinamide on airway and systemic inflammation and antimicrobial peptides in patients with bronchiectasis. In addition, we will evaluate the tolerability and safety of high doses of nicotinamide.
Interventions
Name: Anti-inflammatory and antimicrobial effects of nicotinamide in bronchiectasis.
Dose: 3 g daily for 1 week then 4 g daily for 6 weeks
Study Duration: 8 weeks
Mode of Administration: Oral tablet
Adherence measured by recording tablets issued and returned.
Sponsors
Dr Conroy Wong
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Aged greater than or equal to 18 and less than or equal to 90 years 2. Able to provide written informed consent 3. Able to provide spontaneous sputum sample at visit 2 (week 0). 4. High-resolution CT (HRCT) diagnosis of bronchiectasis, CT scan performed within the past 2 years 5. 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) 6. 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
1. Patients with significant abnormal liver function (AST/ALT greater than 1.5 x upper limit of normal range) or liver cirrhosis 2. Patients taking isoniazid (interaction with nicotinamide) 3. Patients taking sodium valproate or any other known histone deacetylase inhibitor. 4. Patients taking vitamin B3, niacin or nicotinamide supplements within 1 week of commencing study drug. 5. Continuous antibiotic therapy (greater than 3 months) 6. Long term macrolide treatment (greater than or equal to 3 months) in the past 6 months 7. Patients taking continuous oral corticosteroids (greater than 6 weeks) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide). 8. Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic or steroid treatment within 4 weeks of commencing study drug. 9. Patients with a history of non-adherence with medications 10. Patient with significant medical conditions other than bronchiectasis - 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
Outcome results
None listed