Cockroach Nasal Allergen Challenge Pilot

Accrual Objective: N=10 adults, 25 children)

STUDY INCLUSION CRITERIA:

• Subjects fulfilling all of the following criteria are eligible for enrollment as study participants for Phase 1a and Phase 2:
• Subject and/or parent guardian must be able to understand and provide informed consent.
• Male or female adults, 18 through 55 years of age at recruitment (Phase 1) or male or female children, 8-14 years of age at recruitment (Phase 2).
• Have a history of asthma for a minimum of 1 year before study entry:
• A diagnosis of asthma for this study is defined as a reported clinical diagnosis of asthma made by a physician over a year ago.
• The subject must have persistent asthma defined by the current need for at least 100 microgram (mcg) fluticasone per day or the equivalent of another inhaled corticosteroid.
• The subject's asthma must be well controlled as defined by:
• A Forced Expiratory Volume in 1 Second (FEV1) ≥ 80% predicted.
• An Asthma Control Test (ACT) score ≥ 20.
• Are sensitive to German Cockroach as documented by a positive (≥ 3 mm greater than negative control) skin prick test result and a positive German Cockroach specific immunoglobulin E (IgE) (≥0.35 kUA/L).
• Have no known contraindications to the allergenic extracts or diluents.
• Subjects who meet the following criteria are eligible for enrollment as study participants in Phase 1b after completion of Phase 1a:
• Their asthma must be well controlled as defined by:
• A FEV1 ≥ 80% predicted.
• An Asthma Control Test (ACT) score ≥ 20.
• The subject tolerated the Nasal Allergen Challenge (NAC) during Phase 1a with no adverse events grade 2 or higher as determined by "Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (published September 2007) for local reactions to study procedures."
• Subjects not eligible for enrollment as study participants in Phase 1b after completion of Phase 1a if any of the following criteria are met:
• Are pregnant or lactating.
• Have an asthma severity classification of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
• Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
• Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
• Have been treated with depot corticosteroids within the last 12 months.
• Have been hospitalized for asthma within the 12 months prior to their participation in Phase1b.
• Have had an emergency room visit for asthma within the 3 months prior to their participation in Phase 1b.
• 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.
• Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to their participation in Phase 1b.
• Have previously been treated with anti-IgE therapy in the 12 months prior to their participation in Phase 1b.
• 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.
• Have received an investigational drug in the 30 days prior to their participation in Phase 1b.
• 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.
• Meet any of the Participant Stopping Rules and Withdrawal Criteria during Phase 1a
• The p