Oral resveratrol supplementation in bronchiectasis

Phase 2

• Conditions: Respiratory - Other respiratory disorders / diseases; Bronchiectasis

• Registration Number: ACTRN12620000721909
• 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: 2020-07-03
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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 (HRCT) chest scan confirming bronchiectasis within the last 5 years
• Clinically stable during baseline period, for 4 weeks before treatment commencement (defined as 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 1 pulmonary exacerbation requiring antibiotics in the past 12 months

Patients with asthma and/or COPD will be included if the primary diagnosis is bronchiectasis

Exclusion Criteria

• Oral, intravenous or inhaled antibiotics within 4 weeks prior to commencing study
• Patients taking continuous macrolide therapy (for 3 months or longer) within 3 months of screening
• Patients taking continuous oral corticosteroids (for 6 weeks or longer) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide)
• Bronchiectasis exacerbation / respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment
• Use of prescribed or dietary antioxidant supplement within 1 month of screening
• Body mass index <18.5 kg/m2
• Patients with a history of non-compliance with medications
• Patients with significant medical conditions other than bronchiectasis:
• Patients with cystic fibrosis
• Patients with primary ciliary dyskinesia
• Patients with hypogammaglobulinaemia or other primary or acquired immunodeficiency
• Patients with allergic bronchopulmonary aspergillosis
• Pregnant or lactating women
• Participation in a separate clinical or device trial within 4 weeks of screening
• Allergy to any components of Transmax
• Patients with evidence of active or suspected cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sputum neutrophil elastase[Baseline and 12 weeks]