Clinical trial NCT03040596: The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
Official title: The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Vocal Fold Nodules
Keywords: vocal fold nodules
inhaled steroid
steroid
children
nodules
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 2
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: adverse events
timeFrame: 1 year after start of voice therapy
measure: compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
timeFrame: 4 weeks
Secondary outcomes:
measure: fundamental frequency (Hertz)
timeFrame: 9-12 weeks
measure: quality of life questionnaire
timeFrame: 9-12 weeks
measure: maximum phonation time (seconds)
timeFrame: 9-12 weeks
measure: s/z ratio
timeFrame: 9-12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: ENT Department, Children's Hospital of Pittsburgh
name: Joseph Dohar, MD
role: PRINCIPAL_INVESTIGATOR
References: