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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding inhaled corticosteroids (a medication that reduces inflammation) to standard voice therapy can help treat vocal fold nodules, common growths on the vocal cords that affect speech. The main goal is to determine if this combination is safe and effective. Two groups will participate: one will receive both the inhaled medication and voice therapy, while the other will receive only voice therapy. The trial seeks participants who have been newly diagnosed with vocal fold nodules, have not yet undergone voice therapy, and are not currently using inhaled corticosteroids. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that inhaled medications like fluticasone can sometimes cause voice issues, known as dysphonia, as a side effect. Studies have found this occurs in about 5% to 58% of patients. While fluticasone can help with voice problems, it might also cause voice changes in some people.

One study found that more than 70% of patients experienced a reduction or disappearance of their vocal nodules after treatment. This suggests the treatment is effective, but awareness of possible voice-related side effects is important.

Since this trial is in an early phase, it mainly focuses on checking the treatment's safety. Researchers are still learning about how well people handle it and are closely watching for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about combining inhaled corticosteroids with voice therapy for treating vocal nodules because this approach introduces a new delivery method using a fluticasone inhaler. Unlike the typical reliance solely on voice therapy, this method aims to reduce inflammation directly at the site of the nodules, potentially enhancing the effectiveness of traditional therapy. This combination could lead to faster and more significant improvements in voice quality, providing a promising alternative to existing treatments.

What evidence suggests that inhaled corticosteroids and voice therapy could be effective for vocal nodules?

Research has shown that voice therapy alone can effectively treat vocal nodules. One study found that after six months of voice therapy, 84% of children had smaller nodules, and 65% had normal vocal cords. In this trial, one group of participants will receive standard voice therapy alone. Researchers are also testing inhaled medications like fluticasone in another group to see if they can improve these results. Although these medications have been linked to voice issues like hoarseness, they have also shown quick improvements in voice quality for some patients within a few days. Combining inhaled fluticasone with voice therapy might be a more effective treatment for vocal nodules, but more research is needed to confirm this. ^{1 3 6 7 8}

Who Is on the Research Team?

Joseph Dohar, MD

Principal Investigator

ENT Department, Children's Hospital of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199705001116

Inhaled Corticosteroids: Hazardous Effects on Voice—An ... Fluticasone containing ICS was the most frequently prescribed and was the most common cause of hoarseness, SVL abnormalities, and steroid inhaler laryngitis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3496982/

Practical Considerations for Dysphonia Caused by Inhaled ... Budesonide, beclomethasone, and fluticasone are associated with similar rates of dysphonia as an adverse effect, although initial reports have suggested a ...

3. withpower.com withpower.com/trial/phase-1-respiratory-aspiration-2-2017-3c5e4

Inhaled Corticosteroids + Voice Therapy for Vocal Nodules 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9443858/

Use of inhaled versus oral steroids for acute dysphonia They all reported improvements by the 5th day of treatment, with a peak improvement on the 3rd day, and there was no statistical difference in when the ...

5. researchgate.net researchgate.net/publication/391158430_Influence_of_Inhaled_Corticosteroids_on_Voice_Quality_A_Systematic_Review

Influence of Inhaled Corticosteroids on Voice Quality This meta-analysis shows that the addition of salmeterol to moderate doses of ICS (fluticasone 200 mug/day or equivalent) in patients with ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619612006842

Practical Considerations for Dysphonia Caused by Inhaled ... A common local adverse effect of ICS therapy is dysphonia, which has been reported to affect 5% to 58% of patients.

7. impactfactor.org impactfactor.org/PDF/IJCPR/16/IJCPR,Vol16,Issue3,Article8.pdf

Dysphonia: Associated with Inhalation Corticosteroids Video-stroboscopy revealed abnormal laryngeal findings in 66% of patients, including irregular vocal cords, vocal fold atrophy, vocal fold ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5832637/

Ideal particle sizes for inhaled steroids targeting vocal ... This preliminary study suggests that inhalers with larger particle sizes, such as fluticasone propionate DPI, may improve laryngeal drug deposition.