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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)