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Inhaled Corticosteroids + Voice Therapy for Vocal Nodules

Phase 1
Recruiting
Research Sponsored by Joseph Dohar, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently on inhaled corticosteroids
No previous voice therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after start of voice therapy
Awards & highlights

Study Summary

This trial will help determine if a short-course of inhaled corticosteroids in addition to standard voice therapy is safe and effective for treating vocal fold nodules in children.

Who is the study for?
This trial is for children newly diagnosed with vocal fold nodules who can understand and speak English well enough to participate in voice therapy. They should not be on inhaled corticosteroids or have had previous voice therapy, and must be able to attend sessions at Children's Hospital of Pittsburgh.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a short course of an inhaled steroid called Fluticasone propionate, along with standard voice therapy, compared to just the standard therapy alone for treating vocal fold nodules.See study design
What are the potential side effects?
Inhaled corticosteroids like Fluticasone may cause throat irritation, coughing, hoarseness, dry mouth or oral thrush. These side effects are generally mild but vary from child to child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not using inhaled corticosteroids.
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I have never had voice therapy.
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I can understand and speak English well enough for therapy and study requirements.
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I have been recently diagnosed with vocal fold nodules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after start of voice therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after start of voice therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
adverse events
compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
Secondary outcome measures
fundamental frequency (Hertz)
maximum phonation time (seconds)
quality of life questionnaire
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: voice therapy onlyExperimental Treatment1 Intervention
standard voice therapy
Group II: inhaled steroid + voice therapyExperimental Treatment2 Interventions
fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluticasone propionate
2005
Completed Phase 4
~911050

Find a Location

Who is running the clinical trial?

Joseph Dohar, MDLead Sponsor

Media Library

Standard voice therapy Clinical Trial Eligibility Overview. Trial Name: NCT03040596 — Phase 1
Vocal Nodules Research Study Groups: inhaled steroid + voice therapy, voice therapy only
Vocal Nodules Clinical Trial 2023: Standard voice therapy Highlights & Side Effects. Trial Name: NCT03040596 — Phase 1
Standard voice therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03040596 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively recruiting participants who are seventy or older in age?

"The cutoff age for this clinical trial is 11, with prospective participants needing to be at least 4 years old. There are also 20 trials open to minors and 89 available for elderly patients over the age of 65."

Answered by AI

What are the primary goals of this research endeavor?

"This 4-week clinical trial will measure adverse events, along with alterations in fundamental frequency (measured in Hertz), maximum phonation time (in seconds) and s/z ratio."

Answered by AI

Who is the appropriate cohort for this experiment?

"To be accepted in this trial, children must have respiratory aspiration, aged between 4 and 11. A total of 12 participants are being admitted to the study."

Answered by AI

To what disorders is Standard voice therapy typically applied?

"Vocal therapy is an effective method of treating eosinophilic esophagitis (eoe), as well as asthma, allergies to mould and sinus infections."

Answered by AI

Is there still capacity for enrolment in this clinical experiment?

"According to the data hosted on clinicaltrials.gov this medical study, which was initially made available on March 1st 2017, is enrolling volunteers. The details of the trial were most recently edited and updated as of July 8th 2022."

Answered by AI

Is the utilization of Standard voice therapy sanctioned by the FDA?

"Our team at Power assigned a score of 1 to Standard Voice Therapy's safety because this is an initial Phase 1 trial, where the evidence for both safety and efficacy remains sparse."

Answered by AI

What is the total capacity for this clinical research endeavor?

"Affirmative. The clinicaltrials.gov portal conveys that this research is actively enrolling volunteers, with 12 patients needed from 1 site since its March 1st 2017 launch date and most recent July 8th 2022 revision."

Answered by AI

Could you provide a brief overview of the other research conducted related to Standard voice therapy?

"Currently, 10 different clinical trials researching Standard voice therapy are underway. 2 of those active studies have reached Phase 3 status. The majority are located in Palo Alto, California though 14 total sites exist for this specific procedure."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
Joseph Dohar, MD 2017. "The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03040596.
~2 spots leftby Jul 2025
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