Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 16
- 主要终点
- Treatment Failure
研究概览
简要总结
The purpose of the study is to find out if taking vitamin D in addition to an asthma controller medication helps to prevent worsening of asthma symptoms and asthma attacks.
详细描述
This is a randomized, double-blind parallel group trial that will enroll individuals who have vitamin D insufficiency and asthma with persistent symptoms despite low-dose inhaled corticosteroid. Participants on low-dose inhaled corticosteroid will be randomized to add-on therapy with either placebo or high-dose vitamin D for a 28-week period. During the inhaled corticosteroid-stable phase, participants will remain on low-dose inhaled corticosteroid. During the inhaled corticosteroid-taper phase, participants will taper their inhaled corticosteroid by 50% at two time-points post-randomization. The investigators will determine if the addition of vitamin D reduces the likelihood of treatment failure when compared to placebo during both the inhaled corticosteroid-stable and inhaled corticosteroid-taper phases of the study. Given the high prevalence of both vitamin D insufficiency and asthma, this trial has high potential to impact daily asthma management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years of age and older
- •Physician-diagnosed asthma for at least previous 12 months
- •Asthma confirmed by: (a) β-agonist reversibility of forced expiratory volume in 1 second (FEV1) ≥12 % following 180 mcg (4 puffs) levalbuterol at visit 1 OR (b) methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤ 8 mg/ml if not receiving an inhaled corticosteroid or ≤ 16 mg/ml if receiving an inhaled corticosteroid at visit
- •Source documentation for PC20 from an AsthmaNet methacholine challenge completed within 6 months of visit 2 will be accepted.
- •Stable asthma controller therapy (inhaled corticosteroid or leukotriene modifier only) dose for past 2 weeks
- •FEV1 ≥ 50% of predicted at visit 1
- •Vitamin D level of less than 30 ng/ml at visit 0
- •Experienced no more than one treatment failure in the VIDA run-in or oral corticosteroid (OCS) response periods on previous enrollments
- •For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study
排除标准
- •Taking vitamin D supplements containing > 1000 IU/day of vitamin D
- •Taking >2500 mg/day calcium supplements
- •Chronic oral corticosteroid therapy
- •Chronic inhaled corticosteroid therapy > 1,000 mcg of fluticasone daily or the equivalent
- •History of physician-diagnosed nephrolithiasis
- •Use of concomitant medications that alter vitamin D metabolism - phenytoin, phenobarbital, cardiac glycosides; or absorption - orlistat, cholestyramine, colestipol; or those that interfere with study endpoints
- •Impaired renal function (GFR < 30 ml/min)
- •Asthma exacerbation within past 4 weeks requiring systemic corticosteroids
- •Respiratory tract infection within past 4 weeks
- •Chronic diseases (other than asthma)
- •History of cigarette smoking within the past 1 year or > 10 pack years total
- •Serum calcium greater than 10.2 mg/dl on entry
- •Urine calcium/creatinine ratio greater than 0.37 (urinary Ca and Creat in mg)
研究组 & 干预措施
Ciclesonide + placebo
干预措施: Ciclesonide (Drug)
Ciclesonide + Vitamin D
干预措施: Vitamin D3 (Drug)
Ciclesonide + Vitamin D
干预措施: Ciclesonide (Drug)
结局指标
主要结局
Treatment Failure
时间窗: Twenty-eight week intervention period from randomization until end of trial.
Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.
次要结局
- Exacerbations(Overall exacerbation rate during 28-week trial)
- Lung Function Change From Baseline(Change is measured as value at 28 weeks minus baseline value.)
研究者
dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Milton S. Hershey Medical Center