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The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

NCT03040596 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-01-06

No results posted yet for this study

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

Interventions

DRUG

Fluticasone propionate

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

BEHAVIORAL

Standard voice therapy

Standard voice therapy sessions

Sponsors & Collaborators

  • Joseph Dohar, MD

    lead OTHER

Principal Investigators

  • Joseph Dohar, MD · ENT Department, Children's Hospital of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-01-23
Completion
2019-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040596 on ClinicalTrials.gov