The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
Primary Purpose
Vocal Fold Nodules
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluticasone propionate
Standard voice therapy
Sponsored by
About this trial
This is an interventional treatment trial for Vocal Fold Nodules focused on measuring vocal fold nodules, inhaled steroid, steroid, children, nodules
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.
Sites / Locations
- Children's Hospital of Pittsburgh of UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
inhaled steroid + voice therapy
voice therapy only
Arm Description
fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
standard voice therapy
Outcomes
Primary Outcome Measures
adverse events
number and type of adverse events
compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
percent of prescribed doses marked as "taken" on diary
Secondary Outcome Measures
fundamental frequency (Hertz)
change in fundamental frequency from baseline to end of therapy
quality of life questionnaire
change in score from QOL questionnaire from baseline to end of therapy
maximum phonation time (seconds)
change in time from baseline to end of therapy
s/z ratio
change in ratio of 2 measures from baseline to end of therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03040596
Brief Title
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
Official Title
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Dohar, MD
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fold Nodules
Keywords
vocal fold nodules, inhaled steroid, steroid, children, nodules
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inhaled steroid + voice therapy
Arm Type
Experimental
Arm Description
fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
Arm Title
voice therapy only
Arm Type
Other
Arm Description
standard voice therapy
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Other Intervention Name(s)
Flovent
Intervention Description
fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Standard voice therapy
Intervention Description
Standard voice therapy sessions
Primary Outcome Measure Information:
Title
adverse events
Description
number and type of adverse events
Time Frame
1 year after start of voice therapy
Title
compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
Description
percent of prescribed doses marked as "taken" on diary
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
fundamental frequency (Hertz)
Description
change in fundamental frequency from baseline to end of therapy
Time Frame
9-12 weeks
Title
quality of life questionnaire
Description
change in score from QOL questionnaire from baseline to end of therapy
Time Frame
9-12 weeks
Title
maximum phonation time (seconds)
Description
change in time from baseline to end of therapy
Time Frame
9-12 weeks
Title
s/z ratio
Description
change in ratio of 2 measures from baseline to end of therapy
Time Frame
9-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber D Shaffer, PhD
Phone
412-692-6874
Email
shafferad@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Dohar, MD
Organizational Affiliation
ENT Department, Children's Hospital of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen M Mandel, MD
First Name & Middle Initial & Last Name & Degree
Joseph E Dohar, MD
First Name & Middle Initial & Last Name & Degree
Katherine V Abbot, PhD
First Name & Middle Initial & Last Name & Degree
Beverly C Richert, PhD, CRNP
First Name & Middle Initial & Last Name & Degree
Katherine White, MA, CCC-SLP
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
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