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A Study of Sublingual Immunotherapy in Peanut-allergic Children (SLB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597727
First Posted: January 18, 2008
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
Results First Submitted: February 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Food Hypersensitivity
Interventions: Drug: Peanut SLIT
Drug: Placebo SLIT

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Blinded Peanut SLIT Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
Blinded Placebo SLIT Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
Ext Maint Open Label Peanut SLIT After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
Early Unblinded Peanut SLIT Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
Pilot Peanut SLIT Rollover Cohort Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

Participant Flow for 2 periods

Period 1:   12 Month Blinded Phase
    Blinded Peanut SLIT   Blinded Placebo SLIT   Ext Maint Open Label Peanut SLIT   Early Unblinded Peanut SLIT   Pilot Peanut SLIT Rollover Cohort
STARTED   14   15   0   27   4 
COMPLETED   14   15   0   17   3 
NOT COMPLETED   0   0   0   10   1 

Period 2:   Open-label Extended Maintenance Phase
    Blinded Peanut SLIT   Blinded Placebo SLIT   Ext Maint Open Label Peanut SLIT   Early Unblinded Peanut SLIT   Pilot Peanut SLIT Rollover Cohort
STARTED   0 [1]   0 [1]   29 [2]   17   3 
COMPLETED   0   0   23   14   1 
NOT COMPLETED   0   0   6   3   2 
[1] Blinded peanut SLIT + blinded placebo SLIT continued in Ext Open Label Peanut SLIT after unblinding
[2] Blinded peanut SLIT + blinded placebo SLIT continued in Ext Open Label Peanut SLIT after unblinding.



  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
Blinded Peanut SLIT Blinded subjects who received peanut sublingual drops) at the beginning of the study.
Blinded Placebo SLIT

Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.

Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue.

Early Unblinded Peanut SLIT Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
Pilot Peanut SLIT Rollover Cohort Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
Total Total of all reporting groups

Baseline Measures
   Blinded Peanut SLIT   Blinded Placebo SLIT   Early Unblinded Peanut SLIT   Pilot Peanut SLIT Rollover Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   15   27   4   60 
Age 
[Units: Years]
Median (Full Range)
 6.0 
 (2.8 to 10.9) 
 6.6 
 (1.6 to 11.9) 
 6.0 
 (1.5 to 11.8) 
 15.6 
 (8.9 to 20.8) 
 6.4 
 (1.6 to 20.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  35.7%      7  46.7%      6  22.2%      0   0.0%      18  30.0% 
Male      9  64.3%      8  53.3%      21  77.8%      4 100.0%      42  70.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      14 100.0%      15 100.0%      27 100.0%      4 100.0%      60 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   7.1%      1   6.7%      2   7.4%      0   0.0%      4   6.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      1   3.7%      0   0.0%      1   1.7% 
White      13  92.9%      14  93.3%      24  88.9%      3  75.0%      54  90.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      1  25.0%      1   1.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   14   15   27   4   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing   [ Time Frame: 12 months ]

2.  Secondary:   Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing   [ Time Frame: 36-60 months ]


  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
The initial 27 subjects in the study were unblinded in 12/2009 due to concerns for study drug integrity. These subjects were offered reentry into the study on open label drug. 18 accepted and are presented as the Early Unblinded Peanut SLIT cohort.


  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: Edwin Kim, Director UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
phone: 919-843-9087
e-mail: edwinkim@email.unc.edu


Publications of Results:
Other Publications:

Responsible Party: Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597727     History of Changes
Other Study ID Numbers: 11-2296
5R01AT004435-09 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2008
First Posted: January 18, 2008
Results First Submitted: February 7, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017