A randomized placebo-controlled trial to assess efficacy of Vitamin-D supplementation in non-cystic fibrosis bronchiectasis patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 1. Pulmonary exacerbation-free course
研究概览
简要总结
Rationale: Bronchiectasis is a chronic inflammatory condition affecting the airwaysleading to chronic cough with sputum. The management strategy of bronchiectasis(non-CF) usually involves airway clearance therapy, treatment of exacerbations,long-term macrolide therapy and rehabilitation. However, the underlyinginflammation is not addressed by any approved drug. Exacerbations ofbronchiectasis mark events leading to significant morbidity and mortality. Novelty:Vitamin D has shown to be beneficial in certain inflammatory airway disordersbut have not been formally evaluated in non-CF bronchiectasis. If foundbeneficial, it would be the first drug with anti-inflammatory activity to beused in bronchiectasis.
Objectives: The primary objective is to evaluate theeffect of vitamin D on decreasing pulmonary exacerbations at 6 months. Thesecondary objectives are to evaluate the effect of vitamin D on symptomcontrol, quality of life, serum inflammatory markers and sputum microbiome at1, 3 and 6 months.
Methods: In this placebo-controlled triple blindedrandomized controlled trial, 130 patients (65 in each group) would berandomized to either vitamin D or placebo (along with usual care). Consentingpatients without recent infection and fulfilling the inclusion/exclusion criteriawould be enrolled in this study. The different outcomes (exacerbations,symptoms, inflammatory markers, and sputum microbiome) would be assessed atdifferent time points by appropriate tools. Serum neutrophil elastase andcathelicidin would be measured as inflammatory markers.
Expected outcome: It is expected that vitamin D would lead tosignificantly decreased exacerbations, systemic and inflammation and favorablechanges in sputum microbiome over the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between age 14-85 years
- •Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) confirmed by standard criteria (a & b fulfilled and no cystic fibrosis).
- •Are current sputum inducers with a history of chronic expectoration and able to produce sputum sampling.
- •Have mucopurulent or mucoid expectoration at baseline as assessed by sputum color chart (Murray 2009).
- •Must be willing to come for follow-up as per study protocol.
排除标准
- •1.Have a primary diagnosis of asthma and COPD as judged by the investigator.
- •2.Are current smokers.
- •3.Receiving current treatment for non-tuberculous mycobacterial infection, ABPA or tuberculosis.
- •4.Have hypercalcemia at baseline.
- •5.Are not on a stable dose of inhaled corticosteroids for at least 4 week prior to enrolment.
- •6.Have been receiving vitamin-D (>1000 U per week) for > 2 weeks prior to enrolment.
- •7.Patients having hypercalcemia (serum calcium > 10.5 mg/dl or ionized calcium levels > 5.4 mg/dl) 8.Cirrhosis with varices 9.Chronic renal dysfunction requiring dialysis 10.Hyperparathyroidism 11.History of allergy to Vitamin D3 or one of the excipients in the medications 12.Pregnancy and post-partum patients (till 42 days after delivery) 13.Disseminated malignancy, which is active 14.Patients already entered into any trial with intervention for bronchiectasis
- •Have any acute infections (including respiratory infections) that required antibiotic treatment within 4 weeks before Screening or within 12 weeks before Screening if the antibiotic prescription is a macrolide
- •Has been on azole therapy for chronic pulmonary aspergillosis for < 4 weeks.
结局指标
主要结局
1. Pulmonary exacerbation-free course
时间窗: 1. At the end of 6 months | 2.at the end of 1, 3 and 6 months | 3. at the end of 1, 3 and 6 months
2. QOL by BHQ Degreee of symptom control as assessed by Visual analogue scale Change in Pulmonary function (FEV1)
时间窗: 1. At the end of 6 months | 2.at the end of 1, 3 and 6 months | 3. at the end of 1, 3 and 6 months
3. Serum neutrophil elastase and cathelicidin levels
时间窗: 1. At the end of 6 months | 2.at the end of 1, 3 and 6 months | 3. at the end of 1, 3 and 6 months
次要结局
- The difference in composition of the sputum microbiome