Phase 2 N=54 Randomized Double-blind Treatment

Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

Rhinitis, Allergic, Perennial · Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00829985 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Mar 2013

Primary outcome: Primary: Difference in German Cockroach-Specific Serum IgE Over Time — 2.16; 1.12 Ratio — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glycerinated German Cockroach Allergenic Extract (Biological); Placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in German Cockroach-Specific Serum IgE Over Time	2.16; 1.12	<0.0001 sig
SECONDARY Difference in German Cockroach-Specific Serum IgG4 Over Time	1.06; 0.93	0.088
SECONDARY Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)	4.7; 0.7	0.37
SECONDARY Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)	4.0; -1.3	0.09
SECONDARY Percent of Participants With the Occurrence of Adverse Events (AE)	93; 85	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00829985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.