The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
Voice disorders are the most common communication disorder across the lifespan and vocal fold nodules are the most frequent pathology affecting voice in children. The goal of the present study is to determine the safety, feasibility, and efficacy of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.
详细描述
Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States. Vocal fold nodules are the most frequent pathology affecting voice in children, with 21% of children negatively influenced at any given point in time, resulting in negative quality of life consequences and inferior academic performance. The traditional first-line approach to treatment of vocal fold nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often implemented in conjunction with voice therapy to reduce focal inflammation at the lesion site. Operating room procedures are the traditional method to administer corticosteroids to the lesion site, although recent advances in office-based laryngeal steroid injections have become a widely popular alternative to reduce lesion size. Unfortunately, although in-office injections are more favorable to operating room procedures, due to their less invasive nature, in-office procedures are still an invasive alternative in the pediatric population. Specifically, they involve equipment that may be intimidating to the child and require the child to remain very still for prolonged periods of time, which may not be feasible with some children. Furthermore, focal vocal fold injections still involve potential adverse effects such as vocal fold hematoma. To mediate these concerns, a short course of inhaled corticosteroids may be a safe and non-invasive alternative to reducing inflammation and lesion size within the larynx. The goal of the present study is to determine the safety and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules. The study also aims to examine the effects of inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with vocal fold nodules;
- •Considered behaviorally and cognitively appropriate by PI for voice therapy;
- •English comprehension and production sufficient to participate in the protocol and in voice therapy;
- •Not currently on inhaled corticosteroids;
- •No previous voice therapy;
- •Willing to participate in voice therapy at Children's Hospital of Pittsburgh
排除标准
- •Other medical conditions or medications that would mask or amplify voice outcomes, including developmental or other neuromuscular conditions, major illness or disorders, chronic or acute with the exception of laryngopharyngeal reflux disease or allergies and their treatments.
研究组 & 干预措施
inhaled steroid + voice therapy
fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
干预措施: Fluticasone propionate (Drug)
inhaled steroid + voice therapy
fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
干预措施: Standard voice therapy (Behavioral)
voice therapy only
standard voice therapy
干预措施: Standard voice therapy (Behavioral)
结局指标
主要结局
adverse events
时间窗: 1 year after start of voice therapy
number and type of adverse events
compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
时间窗: 4 weeks
percent of prescribed doses marked as "taken" on diary
次要结局
- quality of life questionnaire(9-12 weeks)
- maximum phonation time (seconds)(9-12 weeks)
- fundamental frequency (Hertz)(9-12 weeks)
- s/z ratio(9-12 weeks)
研究者
Joseph Dohar, MD
Professor of Otolaryngology
University of Pittsburgh
