A Phase II Pilot Study to Assess the Safety and Tolerability of Mast Cell Treatment in Post-tick Bite Illness
University of North Carolina, Chapel Hill
Summary
This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).
Description
This Phase II study is designed as a randomized, double-blind study to assess the safety, tolerability, and feasibility of mast cell-directed therapy using ketotifen, cromolyn and fexofenadine vs fexofenadine alone in participants who have post-tick bite illness. The study is a 2 arm, 4-month trial preceded by a 14 day run-in period of fexofenadine for all screened and consented participants. At the end of 14 days, participants will be re-administered the mast cell activation symptom screening questionnaire and those who have a greater than 20% increase in symptom improvement score during 14 d…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Ability to understand and provide informed consent in English (a translator will not be present during screening, consent or follow-up visits) * Age 21-65 years old and of any gender, race, and ethnicity at the time of the initial visit. * History of Ehrlichiosis and/or Rocky Mountain Spotted Fever (RMSF) within the last 36 months diagnosed and treated by a healthcare provider more than 6 months previously with current symptoms causing clinically signific…
Interventions
- DrugKetotifen
Ketotifen is a mast cell stabilizer and H1 antihistamine administered orally at 1 mg twice daily, with dose escalation to 2 mg twice daily after 30 days.
- Drugfexofenadine
Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily
- DrugCromolyn Sodium
Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.
Location
- University of North CarolinaChapel Hill, North Carolina