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The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040596
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph Dohar, MD, University of Pittsburgh

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040596


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

Locations
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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
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Principal Investigator: Joseph Dohar, MD ENT Department, Children's Hospital of Pittsburgh
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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    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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