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

Completed · Phase 1 · Has a placebo group

Conditions studied: Allergy, Asthma

In brief

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.

Key facts

Study ID

NCT00434421

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

28

Starts

2007-02-01

Expected to finish

2009-08-01

Last updated by the study team

2015-06-11

Who can join

Age: 5 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102 — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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