TerminatedPhase 1

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

Stopped: Study drug no longer provided by manufacturer free of charge

United States2 participantsStarted 2017-03-01

Plain-language 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.

Who can participate

Age range4 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

adverse events

Timeframe: 1 year after start of voice therapy

compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)

Timeframe: 4 weeks

Trial details

NCT IDNCT03040596

SponsorJoseph Dohar, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-23

View on ClinicalTrials.gov More Vocal Fold Nodules trials