Cockroach Nasal Allergen Challenge Pilot

Exclusion Criteria

• •1. Are pregnant or lactating.
• •2. Have an asthma severity classification of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
• •1. Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
• •2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
• •3. Have been treated with depot corticosteroids within the last 12 months.
• •4. Have been hospitalized for asthma within the 12 months prior to their participation in Phase1b.
• •5. Have had an emergency room visit for asthma within the 3 months prior to their participation in Phase 1b.
• •6. Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to their participation in Phase 1b.
• •3. Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to their participation in Phase 1b.
• •4. Have previously been treated with anti-IgE therapy in the 12 months prior to their participation in Phase 1b.
• •5. Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants, nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to the nasal allergen challenge in Phase 1b.
• •6. Have received an investigational drug in the 30 days prior to their participation in Phase 1b.
• •7. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• •8. Meet any of the Participant Stopping Rules and Withdrawal Criteria during Phase 1a
• •* The participant elected to withdraw consent from all future study activities, including followup.
• •* The Investigator no longer believes participation is in the best interest of the participant.
• •* Serious Adverse Event (SAE) related to investigational product.
• •* Anaphylactic reaction grade 2 or 3.
• •* Inability to tolerate the NAC prior to reaching a TNSS ≥8 due to excessive discomfort or symptoms.
• •* Epistaxis occurring during the Challenge Visit.
• •* The need to start immunotherapy or any chronic immunosuppressive medications in the period between Phase 1a and Phase 1b.
• •* Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid to maintain asthma control in the period between Phase 1a and Phase 1b.
• •* Inability to restrict use of antihistamines, nasal steroids, nasal decongestants, nasal anticholinergics or cromolyn prior to the NAC.
• •* Development of any serious medical illness whose natural history, sequela, or treatment would be worsened or impaired by continuation in the protocol.
• •* Subject is "lost to follow-up"
• •9. The subject's initial TNSS at the Repeat Challenge Visit must be within 1 point of the initial TNSS at the Challenge Visit in Phase 1a. If the participant's initial TNSS is outside the 1 point range, then the participant may be reevaluated for the Repeat Challenge Visit up to 3 additional times.
• •1. Are pregnant or lactating. Post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception).
• •2. Cannot perform spirometry at Screening.
• •3. Have an asthma severity classification at Recruitment of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
• •1. Require a dose of greater than 500mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
• •2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
• •3. Have been treated with depot corticosteroids within the last 12 months.
• •4. Have been hospitalized for asthma within the 12 months prior to recruitment.
• •5. Have had an emergency room visit for asthma within the 3 months prior to recruitment.
• •6. Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
• •4. Have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy.
• •5. Have active rhinitis symptoms prior to the nasal allergen challenge, defined as a Baseline Total Nasal Symptom Score(TNSS) \>3,with no individual symptom score \>1.
• •6. Do not have access to a phone (needed for scheduling appointments).
• •7. Have received allergen immunotherapy (Sublingual \[SLIT\] or Subcutaneous \[SCIT\]) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study.
• •8. Have previously been treated with anti-IgE therapy in the 12 months prior to recruitment.
• •9. Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants,nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to skin prick testing and the nasal allergen challenge.
• •10. Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study.
• •11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.