Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction

Chronic pelvic pain is a hallmark of patients with CPPS, a non-bacterial category of
prostatitis that is a significant source of morbidity in men. The cause of CPPS is unknown
and there is a lack of biomarkers for diagnosis of this syndrome. Research in animal models
of CP/CPPS have pointed to a role for mast cells and their degranulation constituents
including mast cell tryptase in the development of pelvic pain and lower urinary tract
symptoms. This study aims to evaluate the ability of FDA approved and marketed drugs to
inhibit the release of mast cell tryptase and to ameliorate symptoms in patients with
CP/CPPS.

This is an open label study to evaluate the efficacy of Cromolyn Sodium Oral Solution and
Cetirizine hydrochloride (tablet) in men with CP/CPPS to reduce mast cell tryptase levels in
expressed prostatic fluids and to show improvement in symptoms of CP/CPPS. There is no
control group for the study. The difference between pre- and post-treatment levels across
individuals will be assessed.

The study will consist of 3 periods: the Screening Period (Days -7 to -1), the Treatment
Period (Days 1 to 21), and the Follow-up Period (7 days) after the last dose at Day 21.

During screening, subjects will be admitted to the clinic, undergo specimen (Expressed
prostatic secretions (EPS), urine and blood) collection and recording of their baseline
questionnaire responses Subjects will provide a basic health history, including current
general health, adverse events, medications or treatments within the past 5 years. A physical
examination including vital heart rate, breathing rate, blood pressure, temperature, height,
weight and body mass will be taken. Subsequently, EPS from eligible subjects will be
collected by the clinical team and assayed for the levels of mast cell tryptase within 24
hours of sample collection at the screening visit. 20 subjects with elevated mast cell
tryptase will be identified and will be eligible for receiving the study medication from the
Investigational pharmacy at Northwestern University.

Eligible subjects will be required to take medication for days 1-21 (Week 1-3), record their
symptom scores weekly using the NIH-CPSI, and record all safety related symptoms.

Subjects will return to the clinic after the completion of three weeks of treatment.
Expressed prostatic secretions (EPS), blood as well as a voided bladder 1, 2 and 3 (VB1-3)
urine specimens will be collected as at baseline and after the last dose at day 21 for
evaluating mast cell tryptase levels. A review subject's general health, adverse events, and
any medications that have changed since the last visit will be collected. Vital signs (heart
rate, breathing rate, blood pressure, temperature, weight and BMI will be collected.

Treated subjects will be contacted by phone 7 days after treatment by the study coordinator
to follow up on any study related adverse effects or changes in symptoms.

Inclusion Criteria:

- Male ages 21-80 years old

- Diagnosed with Category III Chronic Pelvic Pain Syndrome

- Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic
Prostatitis Symptom Index (NIH-CPSI).

- CP/CPPS symptoms must have been present for the majority of the time during any 3
months in the previous 6 months.

- Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy
men.

Exclusion Criteria:

- Females

- Males <21 and >80 years old

- Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride

- Patients with impaired renal or hepatic function.

- Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml
based on healthy men.