The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

NCT03040596 | Terminated Phase 1 FDA Drug

• 1 other identifier: STUDY19040139
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Fold Nodules

Keywords

vocal fold nodules; inhaled steroid; steroid; children; nodules

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• fundamental frequency (Hertz)

  9-12 weeks

• quality of life questionnaire

  9-12 weeks

• maximum phonation time (seconds)

  9-12 weeks

• s/z ratio

  9-12 weeks

Study Arms (2)

inhaled steroid + voice therapy

EXPERIMENTAL

fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy

Drug: Fluticasone propionate; Behavioral: Standard voice therapy

voice therapy only

OTHER

standard voice therapy

Behavioral: Standard voice therapy

Interventions

Fluticasone propionate DRUG

fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks

Also known as: Flovent

inhaled steroid + voice therapy

Standard voice therapy BEHAVIORAL

Standard voice therapy sessions

inhaled steroid + voice therapy; voice therapy only

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph Dohar, MD: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Joseph Dohar, MD

  ENT Department, Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 2, 2017
• Study Start: March 1, 2017
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)