The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

Vocal Fold Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03040596
• Other study ID #: STUDY19040139
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2017
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Amber D Shaffer, PhD
• Phone: 412-692-6874
• Email: shafferad[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Vocal Fold Nodules

Intervention

Drug:
• Fluticasone propionate
fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks

Behavioral:
• Standard voice therapy
Standard voice therapy sessions

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Joseph Dohar, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	number and type of adverse events	1 year after start of voice therapy
Primary	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	fundamental frequency (Hertz)	change in fundamental frequency from baseline to end of therapy	9-12 weeks
Secondary	quality of life questionnaire	change in score from QOL questionnaire from baseline to end of therapy	9-12 weeks
Secondary	maximum phonation time (seconds)	change in time from baseline to end of therapy	9-12 weeks
Secondary	s/z ratio	change in ratio of 2 measures from baseline to end of therapy	9-12 weeks