Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

Exclusion Criteria

• •Cannot perform spirometry at screening;
• •Have clinically significant abnormal laboratory values;
• •Have an Asthma classification of severe persistent at screening;
• •Hospitalized for asthma within the 6 months prior to study entry;
• •Life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within the 2 years prior to study entry;
• •No access to a telephone;
• •Received allergen immunotherapy within the last 12 months prior to study entry and plan on initiating or resuming immunotherapy during the study;
• •Treatment with anti-immunoglobulin E (anti-IgE) therapy within 1 year of study entry;
• •Received an investigational drug within the 30 days prior to study entry and plan on using an investigational drug during the study;
• •Experienced nausea, vomiting, abdominal pain or cramps, or diarrhea within the 3 months prior to study entry;
• •Refuse to sign the Epinephrine Auto-injector Training Form;
• •Does not primarily speak English;
• •Plan to move from the area during the study period;
• •History of idiopathic anaphylaxis or anaphylaxis grade 3;
• •Using tricyclic antidepressants or beta-adrenergic blocker drugs;
• •Clinically unacceptable complete blood count (CBC) and liver function tests, as defined by a hemoglobin less than 11.5 in males and 10.0 in females, or platelet counts less than 150,000 and an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than twice the upper limit of normal;
• •Any condition that, in the opinion of the investigator, would interfere with the study; or
• •Pregnant or breastfeeding.