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临床试验/NCT03040596
NCT03040596终止1 期

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: a Pilot Study

Joseph Dohar, MD1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Other

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

发起方
Joseph Dohar, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joseph Dohar, MD

Professor of Otolaryngology

University of Pittsburgh

研究点 (1)

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