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).
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 days of fexofenadine will be considered meaningfully better and not be randomized due to not needing further treatment. Randomized participants (n=50) will be assigned 2:1 by study pharmacy to receive either fexofenadine 180mg daily or ketotifen 1 mg twice daily (starting dose) + cromolyn 200mg three times daily + fexofenadine 180 mg daily. After 30 days, ketotifen will be increased to 2 mg twice daily and remain at that dose until trial completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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.
Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily
Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.
University of North Carolina
Chapel Hill, North Carolina, United States
Change in Mast Cell Activation Symptom Score
Symptoms will be assessed using the mast cell activity symptom scale, which is based on the American Academy of Allergy, Asthma and Immunology scale but with modifications to include neuro/psych symptoms. The construct is a Likert metric with participants ranking symptoms based on categories of frequency, severity and impact to daily life ("bothersome"). Each item is rated on a 4-point scale from 1 ("not at all") to 4 ("extremely") resulting in a range of 63 - 252. Higher scores are correlated with worse symptoms.
Time frame: Baseline, after 4 months of intervention
Change in General Symptoms Questionnaire-30 (GSQ-30) Total Score
The General Symptoms Questionnaire-30 (GSQ-30) is a 30-item patient-reported outcome measure designed to assess multi-system symptom burden. Each item is rated on a 5-point Likert scale from 0 ("not at all") to 4 ("very much"), resulting in a total score ranging from 0 to 120. Higher scores indicate greater symptom burden.
Time frame: Baseline, after 4 months of intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.