Biomarkers of Cockroach Sublingual Immunotherapy 2
BioCSI-2
A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis
1 other identifier
interventional
99
1 country
5
Brief Summary
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started May 2011
Typical duration for phase_1 asthma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
May 30, 2014
CompletedJune 11, 2014
June 1, 2014
1.1 years
June 22, 2011
May 2, 2014
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in German Cockroach-Specific Serum IgE Over Time
Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Baseline through 3 months of treatment
Secondary Outcomes (4)
Change in German Cockroach-Specific Serum IgG Over Time
Baseline through 3 months of treatment
Change in German Cockroach-Specific Serum IgG4 Over Time
Baseline through 3 months of treatment
Change in IgE Fragment Antibody Binding (FAB) Activity Over Time
Baseline through 3 months of treatment
Percent of Participants With the Occurrence of Adverse Events (AEs)
Participant enrollment to end of study (up to 3 months post-baseline)
Study Arms (3)
Cockroach Sublingual Immunotherapy (SLIT) - Low Dose
EXPERIMENTALGlycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily
Placebo
PLACEBO COMPARATORPlacebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization)
Cockroach Sublingual Immunotherapy (SLIT) - High Dose
EXPERIMENTALGlycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily
Interventions
Participants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \[w/v\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
Participants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \[w/v\]) was achieved.
Participants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \[w/v\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
Eligibility Criteria
You may qualify if:
- Have a history of perennial allergic rhinitis, asthma, or both, before study entry. For those with asthma:
- a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
- the participant's asthma must be well controlled as defined by: ii. a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication ii. albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
- Are sensitive to German cockroach (Blattella germanica) as documented by a positive (\>/=3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (\>/=0.35 kUA/L)
- Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo
- Parent or legally authorized representative (LAR) of child is willing to sign the written Informed Consent prior to initiation of any study procedure
You may not qualify if:
- Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
- Cannot perform spirometry or peak flow at screening
- Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
- requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
- have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
- have been treated with depot steroids within the last 12 months
- have been hospitalized for asthma within the 6 months prior to recruitment
- have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
- Do not have access to a phone (needed for scheduling appointments)
- Have received allergen immunotherapy in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study
- Have previously been treated with anti-IgE therapy within 1 year of recruitment
- Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
- Have in the last 3 months prior to recruitment experienced on average \>/=1 day per week any of the symptoms below:
- nausea or vomiting
- abdominal pain or cramps severe enough to interfere with daily activities (excluding those associated with menstruation).
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.
PMID: 24184147RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Robert Wood, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2011
First Posted
June 27, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 11, 2014
Results First Posted
May 30, 2014
Record last verified: 2014-06