Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)
United States54 participantsStarted 2009-01
Plain-language summary
There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach extract given to adults with perennial allergic rhinitis, asthma, or both.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of perennial allergic rhinitis, asthma, or both for a minimum of 1 year prior to study entry;
* Positive skin prick test to German cockroach;
* No known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo; and
* Willing to sign the written Informed Consent prior to initiation of any study procedures.
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 o…
What they're measuring
1
Difference in German Cockroach-Specific Serum IgE Over Time
Timeframe: Baseline through 6-months of treatment
Trial details
NCT IDNCT00829985
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)