Treatment of Indolent Systemic Mastocytosis With PA101

Exclusion Criteria

• •Advanced systemic mastocytosis (i.e., aggressive systemic mastocytosis \[ASM\], mast cell leukemia \[MCL\], or systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease \[SM-AHNMD\] )
• •Current or recent history of clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that could put the patient at risk or compromise the quality of the study data as determined by the Investigator
• •Use of oral cromolyn sodium within 6 weeks of Screening
• •History of systemic corticosteroid, immunosuppressive, or anti-IgE monoclonal antibody therapy (e.g., omalizumab) within 6 months of Screening
• •History of anaphylaxis requiring systemic treatment (i.e., corticosteroid or epinephrine) within 12 months of Screening
• •Upper or lower respiratory tract infection within 4 weeks of Screening
• •History of malignancy within the last 5 years, except basal cell carcinoma or cervix carcinoma in situ
• •Major surgery within 6 months of Screening
• •Current or recent history (within 12 months) of excessive use or abuse of alcohol
• •Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances
• •Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
• •Participation in any other investigational drug study within 4 weeks of Screening
• •History of hypersensitivity or intolerance to aerosol medications or cromolyn sodium