Efficacy of Oral Prednisolone Versus Placebo in the Management of Acute Laryngitis in Vocal Professionals: A Randomized Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of oral corticosteroid therapy, specifically **prednisolone**, compared with placebo in the treatment of **acute laryngitis** among vocal professionals and singers. This is clinically relevant as acute laryngitis can significantly impact vocal performance, and effective management is crucial for individuals who rely on their voice for professional purposes. The study aims to determine whether corticosteroid therapy can provide a therapeutic benefit in reducing symptoms and improving vocal function in this population.

The clinical trial focuses on evaluating the efficacy of oral corticosteroid therapy compared with placebo in the treatment of **acute laryngitis** among vocal professionals and singers. The study population includes both male and female participants, aged between 18 and 64 years, who are either vocal professionals or individuals studying to become one. Participants are required to have experienced hoarseness that began during or after flu symptoms and has persisted for less than three weeks. All participants must be fluent in the Finnish language. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the **efficacy** of oral corticosteroid therapy compared with placebo in the treatment of **acute laryngitis** among vocal professionals and singers. This is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thus minimizing bias. The trial is categorized as a Phase IV study, indicating it is conducted after the product has been marketed to gather additional information on the drug's effect in a larger population. The trial is expected to run from November 7, 2022, to December 31, 2027, with participant involvement lasting up to four weeks.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as hoarseness starting during or after flu symptoms, fluency in Finnish, age between 18 and 64 years, and being a vocal professional or in training. Following successful screening, participants will be randomized to receive either the active treatment, **Prednisolone 20 mg tablets**, or a placebo, both administered orally. The primary endpoint is the duration of vocal symptoms, while secondary endpoints include inflammatory findings of the larynx, particularly in the vocal cords, as observed through laryngoscopy.

Follow-up visits will be scheduled to monitor the participants' progress and any adverse effects. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study protocol, or choose to withdraw consent. The trial aims to provide valuable insights into the management of acute laryngitis in a specific population, contributing to the optimization of treatment strategies.

The clinical trial involves the administration of **Prednisolone**, a corticosteroid, as the experimental medication. Prednisolone is provided in the form of 20 mg tablets, manufactured by Orifarm Healthcare A/S. The tablets are intended for **oral** administration. The dosing regimen allows for a maximum daily dose of 50 mg, with a total maximum dose of 140 mg over the course of the treatment period. The treatment duration is limited to a maximum of 4 weeks. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen.

The study also includes a **placebo** as a non-experimental treatment to serve as a comparator. The placebo is presented as a white, flat, round, uncoated tablet with a diameter of 9 mm. The placebo tablets are designed to be indistinguishable from the active medication in appearance to maintain the blinding of the study. The placebo is administered orally, following the same dosing schedule as the active treatment, to ensure consistency in administration and to facilitate accurate comparison of outcomes between the treatment groups.

The efficacy of the treatment in the clinical trial titled "Corticosteroid in treatment of acute laryngitis among vocal professionals" will be assessed using specific endpoints. The primary endpoint for evaluating efficacy is the duration of the vocal symptoms experienced by participants. This will provide a direct measure of symptom improvement over the course of the treatment. Additionally, a secondary endpoint involves assessing inflammatory findings of the larynx, particularly in the vocal cords, through laryngoscopy. This will help determine the extent of inflammation reduction as a result of the treatment.

The trial aims to compare the efficacy of oral corticosteroid therapy with a placebo in treating acute laryngitis among vocal professionals and singers. The assessment of these endpoints will be conducted at predetermined intervals throughout the trial to ensure comprehensive data collection and analysis. The use of laryngoscopy as a tool for evaluating secondary endpoints ensures that the assessment of inflammation is both accurate and reliable. The trial is designed to provide robust data on the effectiveness of corticosteroid treatment in this specific patient population.