Inhaled Corticosteroids + Voice Therapy for Vocal Nodules

Overseen By Amber D Shaffer, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Joseph Dohar, MD

Disqualifiers: Neuromuscular conditions, Major illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

2 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have other medical conditions or are on medications that could affect voice outcomes, you may be excluded from the trial.

What data supports the idea that Inhaled Corticosteroids + Voice Therapy for Vocal Nodules is an effective treatment?

The available research shows that voice therapy, often combined with treatments like inhaled corticosteroids, is effective for vocal nodules. One study found that over 70% of patients experienced a reduction or elimination of nodules, and more than 80% had improved voice quality after therapy. Another study in a school setting showed that after six months of voice therapy, 84% of children had reduced nodule size, and 65% had normal vocal cords. These results suggest that this combined treatment is effective in improving vocal nodules. ^{1 2 3 4 5}

What safety data is available for inhaled corticosteroids and voice therapy in treating vocal nodules?

The safety data for inhaled corticosteroids and voice therapy in treating vocal nodules includes findings from several studies. One study on dysphonia and inhaled corticosteroids showed that asthmatics had more vocal fold pathology than healthy controls, but improvements were noted after starting inhaled steroid therapy, with some cases showing resolution of vocal fold nodules. However, there is a risk of steroid-induced myopathy, as seen in one case. Voice therapy studies indicate effectiveness in reducing or eliminating vocal nodules, with over 70% of patients showing improvement and over 80% achieving normal or mildly dysphonic voice quality post-therapy. Laryngeal steroid injections are also discussed as a treatment option, especially for those with voice-related occupations where traditional voice therapy is challenging. ^{1 2 6 7 8}

Is standard voice therapy a promising treatment for vocal nodules?

Yes, standard voice therapy is promising because it has been shown to eliminate or reduce vocal nodules in over 70% of cases, and more than 80% of patients have improved voice quality after therapy. ^{1 6 9 10 11}

Research Team

Joseph Dohar, MD

Principal Investigator

ENT Department, Children's Hospital of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

I am not using inhaled corticosteroids.

I am willing to undergo voice therapy at Children's Hospital of Pittsburgh.

Considered behaviorally and cognitively appropriate by PI for voice therapy

Exclusion Criteria

I don't have conditions or take medications that would affect my voice, except for reflux or allergies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inhaled corticosteroids and standard voice therapy

4 weeks

Regular visits for therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

9-12 weeks

Periodic assessments

Long-term follow-up

Monitoring of adverse events and long-term outcomes

1 year

Treatment Details

Interventions

• Fluticasone propionate
• Standard voice therapy

Trial Overview 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.

Participant Groups

Group I: voice therapy only Experimental Treatment 1 Intervention

standard voice therapy

Group II: inhaled steroid + voice therapy Experimental Treatment 2 Interventions

fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy

Standard voice therapy is already approved in United States, European Union for the following indications:

Approved in United States as Standard Voice Therapy for:

• Vocal Fold Nodules
• Benign Vocal Cord Lesions

Approved in European Union as Speech-Language Pathology for:

• Vocal Fold Nodules
• Voice Disorders

Who Is Running the Clinical Trial?

Joseph Dohar, MD

Lead Sponsor

Trials

1

Recruited

2+

Findings from Research

In a retrospective audit of 26 clinical files over six years, treatment for vocal fold nodules resulted in the elimination or reduction of nodules in over 70% of patients.

Post-therapy assessments showed that over 80% of patients achieved normal voice quality or only mild dysphonia, indicating effective management of vocal fold nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice therapy outcomes in vocal fold nodules: a retrospective audit. McCrory, E.[2019]

In a study involving 53 women with vocal nodules, both intensive voice treatment and traditional voice treatment led to improvements in voice function, vocal health, and communication, indicating that both methods are effective.

Physiological improvements were noted after just vocal hygiene education, and there were no significant differences in outcomes between the two treatment approaches, suggesting that intensive therapy may not provide additional benefits over traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive versus traditional voice therapy for vocal nodules: perceptual, physiological, acoustic and aerodynamic changes. Fu, S., Theodoros, DG., Ward, EC.[2015]

Voice therapy is an effective first-line treatment for benign voice disorders such as vocal nodules, polyps, and muscle tension dysphonia, with significant improvements in voice quality and patient-reported outcomes after treatment.

Adherence to voice therapy sessions and the level of vocal demand in a patient's occupation are important factors that influence treatment success, with higher adherence and greater vocal demand leading to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-dimensional investigation of the clinical effectiveness and prognostic factors of voice therapy for benign voice disorders. Lin, FC., Chien, HY., Kao, YC., et al.[2021]

Over 80% of the 126 patients treated with vocal fold steroid injection (VFSI) reported subjective improvements in their voice quality, with significant objective improvements noted in most outcome measures after 1 and 2 months.

Certain factors, such as higher occupational vocal demands and the presence of fibrotic nodules, were linked to poorer treatment responses, while side effects like hematoma were common but mostly resolved on their own within 1-2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Outcome Researches of Intralesional Steroid Injection on Benign Vocal Fold Lesions. Wang, CT., Lai, MS., Hsiao, TY.[2022]

In a study involving 34 children with vocal nodules, 31 received treatment, and after two months of voice therapy, 68% showed reduced nodule size, while 23% had normal larynges.

After six months of therapy, 84% of the children had reduced nodule size, and 65% achieved normal laryngeal conditions, indicating the effectiveness of the treatment procedures used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification, evaluation, therapy, and follow-up for children with vocal nodules in a public school setting. Deal, RE., McClain, B., Sudderth, JF.[2019]

Laryngeal steroid injection, performed under topical anesthesia with a laryngeal telescope or flexible endoscope, offers a minimally invasive and effective treatment option for vocal nodules, especially for patients who struggle with voice rest and therapy due to their voice-related occupations.

This method has been shown to improve key vocal parameters, such as maximum phonation time and mean flow rate, although the existing literature on its efficacy is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal steroid injection. Tateya, I.[2009]

Asthmatics showed significantly more vocal fold pathology compared to healthy controls, with 10 out of 20 asthmatics exhibiting erythema and edema after three months of high-dose inhaled steroid therapy.

After treatment, two of the six hoarse asthmatics experienced voice improvement, linked to the resolution of vocal fold nodules and edema, although one patient developed a mid glottic chink, suggesting potential complications from steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dysphonia and inhalation of corticoids: a prospective study]. Hone, SW., Donnelly, MJ., Robertson, J., et al.[2006]

The pilot study involving 10 women with vocal fold nodules showed significant improvements in vocal function and quality of life after receiving intensive voice therapy via telepractice over 3 weeks, indicating that this method can be effective.

Participants reported high satisfaction with telepractice, and the outcomes were comparable to traditional face-to-face therapy, suggesting that telepractice could be a viable alternative for treating vocal fold nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Intensive Voice Therapy for Vocal Fold Nodules Via Telepractice: A Pilot Feasibility and Efficacy Study. Fu, S., Theodoros, DG., Ward, EC.[2022]

In a study of 48 patients with chronic hypertrophic laryngitis, Betamethasone injections significantly improved voice quality and reduced vocal cord congestion or edema, achieving an overall effectiveness rate of 86.96%.

After six months, 21.74% of patients were completely cured, and 47.83% showed significant improvement, indicating that Betamethasone is an effective treatment for voice hoarseness associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Betamethasone injection in chronic hypertrophic laryngitis]. Ni, GS., Qiao, Y., Chen, WW.[2019]

Pediatric otolaryngologists play a crucial role in diagnosing and treating voice disorders like dysphonia and rhinophony, with a focus on identifying organic causes and understanding the functional aspects related to voice misuse and environmental factors.

Surgical intervention for hyperrhinophony has a high success rate, with 90% of patients experiencing significant improvement post-surgery, and the ideal age for such operations is around 4.5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice disorders in children. Hirschberg, J., Dejonckere, PH., Hirano, M., et al.[2019]

Vocal fold nodules are a common cause of hoarseness, significantly impacting individuals' quality of life, and their treatment primarily involves conservative methods such as voice rest, medication, and voice therapy.

Surgical intervention, specifically laryngomicrosurgery using a suspension laryngoscope, is considered a supplementary option when conservative treatments are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in diagnosis and treatment of vocal fold nodules]. Cao, CL., Wang, BQ.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Voice therapy outcomes in vocal fold nodules: a retrospective audit. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intensive versus traditional voice therapy for vocal nodules: perceptual, physiological, acoustic and aerodynamic changes. [2015]

3. Singapore pubmed.ncbi.nlm.nih.gov

Multi-dimensional investigation of the clinical effectiveness and prognostic factors of voice therapy for benign voice disorders. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Outcome Researches of Intralesional Steroid Injection on Benign Vocal Fold Lesions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Identification, evaluation, therapy, and follow-up for children with vocal nodules in a public school setting. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Laryngeal steroid injection. [2009]

7. France pubmed.ncbi.nlm.nih.gov

[Dysphonia and inhalation of corticoids: a prospective study]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Delivery of Intensive Voice Therapy for Vocal Fold Nodules Via Telepractice: A Pilot Feasibility and Efficacy Study. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Betamethasone injection in chronic hypertrophic laryngitis]. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Voice disorders in children. [2019]

11. China pubmed.ncbi.nlm.nih.gov

[Progress in diagnosis and treatment of vocal fold nodules]. [2018]