The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

Study Overview
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Brief Summary
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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 and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.

Detailed Description
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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.

Official Title
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The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study

Conditions
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Vocal Fold Nodules

Intervention / Treatment
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* Drug: Fluticasone propionate
* Behavioral: Standard voice therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled steroid + voice therapy<br>fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy | Drug: Fluticasone propionate<br>* fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks<br>* Other names: Flovent;Behavioral: Standard voice therapy<br>* Standard voice therapy sessions<br>|
| Other: voice therapy only<br>standard voice therapy | Behavioral: Standard voice therapy<br>* Standard voice therapy sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | number and type of adverse events | 1 year after start of voice therapy | 
| compliance with inhaler use (percent of prescribed doses marked as taken on diary) | percent of prescribed doses marked as taken on diary | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fundamental frequency (Hertz) | change in fundamental frequency from baseline to end of therapy | 9-12 weeks | 
| quality of life questionnaire | change in score from QOL questionnaire from baseline to end of therapy | 9-12 weeks | 
| maximum phonation time (seconds) | change in time from baseline to end of therapy | 9-12 weeks | 
| s/z ratio | change in ratio of 2 measures from baseline to end of therapy | 9-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vocal fold nodules, inhaled steroid, children, nodules, steroid