The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

NCT ID: NCT03040596

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-01-23

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.

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.

Conditions

Vocal Fold Nodules

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

inhaled steroid + voice therapy

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

Group Type: EXPERIMENTAL

Fluticasone propionate

Intervention Type: DRUG

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

Standard voice therapy

Intervention Type: BEHAVIORAL

Standard voice therapy sessions

voice therapy only

standard voice therapy

Group Type: OTHER

Standard voice therapy

Intervention Type: BEHAVIORAL

Standard voice therapy sessions

Interventions

Fluticasone propionate

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

Intervention Type: DRUG

Standard voice therapy

Standard voice therapy sessions

Intervention Type: BEHAVIORAL

Other Intervention Names

Flovent

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph Dohar, MD

OTHER

Sponsor Role: lead

Responsible Party

Joseph Dohar, MD

Professor of Otolaryngology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Dohar, MD

Role: PRINCIPAL_INVESTIGATOR

ENT Department, Children's Hospital of Pittsburgh

Locations

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19040139

Identifier Type: -

Identifier Source: org_study_id