Clinical trial

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

Name

STUDY19040139

Description

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.

Trial arms

Trial start

2017-03-01

Estimated PCD

2025-07-01

Trial end

2026-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Fluticasone propionate

fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks

Arms:

inhaled steroid + voice therapy

Other names:

Flovent

Standard voice therapy

Standard voice therapy sessions

Arms:

inhaled steroid + voice therapy, voice therapy only

Size

Primary endpoint

adverse events

1 year after start of voice therapy

compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)

4 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2024-01-09

1 organization

1 product

1 indication

Organization

Joseph Dohar, MD

Product

Fluticasone propionate

Indication

Vocal Cord Nodules