Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Inner-City Asthma Consortium

Criteria

Inclusion Criteria for All Participants:

• History of perennial allergic rhinitis with or without asthma for a minimum of 1 year prior to study entry

• Positive skin prick test to German cockroach performed along with negative (saline) and positive (histamine) controls

• Willing to sign EpiPen training form

• Parent or guardian willing to provide informed consent, if applicable

Inclusion Criteria for Participants with Asthma:

• Diagnosis of well-controlled, mild to moderate persistent asthma, defined as having symptoms at least 3 times a week with no controller medication OR less than 3 times a week on controller medication. More information about this criterion can be found in the protocol.

• Diagnosis of asthma made over 1 year prior to study entry

Exclusion Criteria:

• Have severe, persistent asthma (according to National Asthma Education and Prevention Program [NAEPP] classification) as evidenced by those who require a dose of greater than 500 mcg of fluticasone/day or equivalent of another inhaled corticosteroid OR who have been hospitalized for asthma within 6 months prior to study entry

• Life-threatening asthma exacerbation requiring intubation or mechanical ventilation or resulting in a hypoxic seizure in the 2 years prior to study entry

• History of anaphylaxis of Grade 2 or higher as defined in the protocol

• Unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunologic diseases that, in the opinion of the investigator, may interfere with the study or pose additional risk to the patient. More information about this criterion can be found in the protocol.

• Taking medications that could induce gastrointestinal reactions during the study. Participants taking such medications must prove to be stable with no side effects for at least 3 months prior to study screening to be considered eligible.

• Received an investigational drug in the 30 days prior to study entry OR plan to receive an investigational drug during the study

• Received allergen immunotherapy in the 180 days prior to screening or plan to initiate or resume allergen immunotherapy during the study

• Taking tricyclic antidepressants or beta-adrenergic blocker drugs

• Received omalizumab in the 3 months prior to study screening

• Known contraindication to therapy with cockroach extract used in this study

• Mental illness that would interfere with the participant's ability to comply to study requirements

• History of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study

• Plan to leave study area during the study

• Does not primarily speak English, including caretakers of participants when the participant is a child

• Cannot perform spirometry

• Pregnant or breastfeeding