Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)

This study has been completed.
Sponsor:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00829985
First received: January 26, 2009
Last updated: March 11, 2013
Last verified: March 2013
Results First Received: January 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Rhinitis, Allergic, Perennial
Asthma
Interventions: Biological: Glycerinated German Cockroach Allergenic Extract
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Four National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium (ICAC) sites in the United States recruited the targeted number of study participants who fulfilled entry criteria between January and June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glycerinated German Cockroach Allergenic Extract Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
Placebo Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.

Participant Flow:   Overall Study
    Glycerinated German Cockroach Allergenic Extract     Placebo  
STARTED     28     26  
COMPLETED     19     22  
NOT COMPLETED     9     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glycerinated German Cockroach Allergenic Extract Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
Placebo Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
Total Total of all reporting groups

Baseline Measures
    Glycerinated German Cockroach Allergenic Extract     Placebo     Total  
Number of Participants  
[units: participants]
  28     26     54  
Age  
[units: years]
Mean ± Standard Deviation
  31  ± 9.9     33  ± 11.4     32  ± 10.6  
Gender  
[units: participants]
     
Female     21     17     38  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
United States     28     26     54  
German Cockroach-Specific Serum IgE Levels  
[units: kU/L]
Median ( Full Range )
  1.9  
  ( 0.4 to 150 )  
  2.9  
  ( 0.4 to 113.3 )  
  2.0  
  ( 0.4 to 150 )  
German Cockroach-Specific Serum Immunoglobulin Subclass 4 (IgG4) Levels  
[units: mg/mL]
Median ( Full Range )
  0.19  
  ( 0.01 to 3.59 )  
  0.08  
  ( 0.02 to 1.03 )  
  0.09  
  ( 0.01 to 3.59 )  



  Outcome Measures
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1.  Primary:   Difference in German Cockroach-Specific Serum IgE Over Time   [ Time Frame: Baseline through 6-months of treatment ]

2.  Secondary:   Difference in German Cockroach-Specific Serum IgG4 Over Time   [ Time Frame: Baseline through 6-months of treatment ]

3.  Secondary:   Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)   [ Time Frame: Baseline through 6-months of treatment ]

4.  Secondary:   Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)   [ Time Frame: Baseline through 6-months of treatment ]

5.  Secondary:   Percent of Participants With the Occurrence of Adverse Events (AE)   [ Time Frame: Participant enrollment to end of study (up to 6 months post-baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00829985     History of Changes
Other Study ID Numbers: DAIT ICAC-12, BioCSI
Study First Received: January 26, 2009
Results First Received: January 31, 2013
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration