Status:
COMPLETED
Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Inner-City Asthma Consortium
Conditions:
Rhinitis, Allergic, Perennial
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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 plac...
Detailed Description
Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asth...
Eligibility Criteria
Inclusion
- 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
- 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 or anaphylaxis grade 3;
- Using tricyclic antidepressants or beta-adrenergic blocker drugs;
- Clinically unacceptable complete blood count (CBC) and liver function tests, as defined by a hemoglobin less than 11.5 in males and 10.0 in females, or platelet counts less than 150,000 and an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than twice the upper limit of normal;
- Any condition that, in the opinion of the investigator, would interfere with the study; or
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00829985
Start Date
January 1 2009
End Date
December 1 2009
Last Update
March 21 2017
Active Locations (4)
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1
National Jewish Center
Denver, Colorado, United States, 80206
2
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
3
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
4
Boston University School of Medicine
Boston, Massachusetts, United States, 02118