The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

• ClinicalTrials.gov Identifier: NCT03040596
• Recruitment Status: Recruiting
• First Posted: February 2, 2017
• Last Update Posted: August 6, 2020
• Sponsor: Joseph Dohar, MD
• Information provided by (Responsible Party): Joseph Dohar, MD, University of Pittsburgh

Study Description

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 and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.

Condition or disease	Intervention/treatment	Phase
Vocal Fold Nodules	Drug: Fluticasone propionate; Behavioral: Standard voice therapy	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2023

Arms and Interventions

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 Name: Flovent; Behavioral: Standard voice therapy; Standard voice therapy sessions
voice therapy only; standard voice therapy	Behavioral: Standard voice therapy; Standard voice therapy sessions

Outcome Measures

Primary Outcome Measures :

1. adverse events [ Time Frame: 1 year after start of voice therapy ]
   number and type of adverse events
2. compliance with inhaler use (percent of prescribed doses marked as "taken" on diary) [ Time Frame: 4 weeks ]
   percent of prescribed doses marked as "taken" on diary

Secondary Outcome Measures :

1. fundamental frequency (Hertz) [ Time Frame: 9-12 weeks ]
   change in fundamental frequency from baseline to end of therapy
2. quality of life questionnaire [ Time Frame: 9-12 weeks ]
   change in score from QOL questionnaire from baseline to end of therapy
3. maximum phonation time (seconds) [ Time Frame: 9-12 weeks ]
   change in time from baseline to end of therapy
4. s/z ratio [ Time Frame: 9-12 weeks ]
   change in ratio of 2 measures from baseline to end of therapy

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ellen M Mandel, MD; 412-692-5463; ellen.mandel@chp.edu

Locations

United States, Pennsylvania

Children's Hospital of Pittsburgh of UPMC; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Sub-Investigator: Ellen M Mandel, MD

Principal Investigator: Joseph E Dohar, MD

Sub-Investigator: Katherine V Abbot, PhD

Sub-Investigator: Beverly C Richert, PhD, CRNP

Sub-Investigator: Katherine White, MA, CCC-SLP

Sponsors and Collaborators

Joseph Dohar, MD

Investigators

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

More Information

• Responsible Party: Joseph Dohar, MD, Professor of Otolaryngology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03040596
• Other Study ID Numbers: PRO14080577
• First Posted: February 2, 2017
• Last Update Posted: August 6, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Joseph Dohar, MD, University of Pittsburgh:

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

Additional relevant MeSH terms:

Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Fluticasone; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents