Mouthwash for Asthma

(EVOOW Trial)

This trial tests whether a mouthwash made from extra virgin olive oil and water can reduce leftover fluticasone propionate, a common asthma medication, in the mouth. By removing more of this medication, the trial aims to lower the risk of issues like sleep apnea, thrush, and swallowing problems. The study compares two versions of the mouthwash: one with equal parts oil and water, and another with more oil than water. It suits people with asthma who experience frequent symptoms and are willing to pause their inhaler use briefly during the study. Participants will engage for about three weeks, trying different rinses on separate days. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

You will need to stop using inhaled corticosteroids (medications for asthma) for 24 hours if taken by mouth and 12 hours if taken by nose before certain study visits. You cannot use any other corticosteroids for 4 weeks before the trial.

Research has shown that Fluticasone Propionate, a medication for asthma, is generally safe for patients. Studies have found that while some people might experience side effects like mild asthma flare-ups or nasal irritation, serious side effects are rare. For instance, one study found that about 37% of patients reported some side effects, but these were usually not severe.

Researchers are excited about using a mouthwash protocol with Fluticasone Propionate (FP) for asthma because it introduces a unique delivery method to manage the condition. Unlike standard asthma treatments, which typically involve inhalers or oral medications, this trial explores the potential of rinsing and gargling with a mixture of water and extra virgin olive oil water (EVOOW) after FP administration. This innovative approach could potentially minimize side effects associated with oral corticosteroids and improve patient adherence by offering a simpler, more pleasant administration route. The trial aims to determine if this method can offer effective asthma control while enhancing user experience.

Research has shown that Fluticasone Propionate (FP) improves asthma control. Studies found that taking FP for 12 weeks, in doses of 100 to 500 micrograms twice a day, was more effective than a placebo. Patients experienced better asthma management, with their asthma control scores increasing from an average of 16.3 to 19.8. Fluticasone also significantly reduces the number of severe asthma flare-ups. In this trial, participants will receive FP and then rinse and gargle with either water or an EVOOW mix, assigned in random order. Additionally, Fluticasone effectively treats other conditions like nasal allergies and emphysema, a lung disease.¹²⁶⁷⁸