The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: a Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Vocal Fold Nodules
• Intervention / Treatment: Drug: Fluticasone propionate; Behavioral: Standard voice therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Joseph Dohar, MD
• Investigators: Principal Investigator: Joseph Dohar, MD, ENT Department, Children's Hospital of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): January 23, 2019

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimated): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: children; steroid; vocal fold nodules; inhaled steroid; nodules
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Dermatologic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: STUDY19040139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No