This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01084174
First received: March 8, 2010
Last updated: February 23, 2017
Last verified: February 2017
Results First Received: February 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Peanut Hypersensitivity
Food Hypersensitivity
Immediate Hypersensitivity
Interventions: Drug: Peanut powder
Drug: Peanut extract
Drug: Placebo extract
Drug: Placebo powder

  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
Active SLIT/Placebo OIT

These subjects will receive peanut powder given orally and placebo extract given sublingually.

Peanut powder: Delivered orally

Placebo extract: Delivered sublingually

Active OIT/Placebo SLIT

These subjects will receive peanut extract given sublingually and placebo powder given orally.

Peanut extract: Delivered sublingually

Placebo powder: Delivered orally


Participant Flow:   Overall Study
    Active SLIT/Placebo OIT   Active OIT/Placebo SLIT
STARTED   10   11 
COMPLETED   9   7 
NOT COMPLETED   1   4 
gastrointestinal symptoms                1                1 
Eosinophilic esophagitis                0                1 
Anaphylaxis                0                1 
Participant noncompliance                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Active SLIT/Placebo OIT

These subjects will receive peanut powder given orally and placebo extract given sublingually.

Peanut powder: Delivered orally

Placebo extract: Delivered sublingually

Active OIT/Placebo SLIT

These subjects will receive peanut extract given sublingually and placebo powder given orally.

Peanut extract: Delivered sublingually

Placebo powder: Delivered orally

Total Total of all reporting groups

Baseline Measures
   Active SLIT/Placebo OIT   Active OIT/Placebo SLIT   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      10 100.0%      11 100.0%      21 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  60.0%      4  36.4%      10  47.6% 
Male      4  40.0%      7  63.6%      11  52.4% 
Region of Enrollment 
[Units: Participants]
     
United States   10   11   21 
Prior history of peanut anaphylaxis 
[Units: Participants]
Count of Participants
 1   6   7 
Other food allergies 
[Units: Participants]
Count of Participants
 10   10   20 
Atopic dermatitis 
[Units: Participants]
Count of Participants
 6   6   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Induced Peanut Desensitization at 12 Months   [ Time Frame: 12 months ]

2.  Secondary:   Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)   [ Time Frame: Baseline and end of dose build-up (up to 16 weeks) ]

3.  Secondary:   Between Arm Change in IgG4 From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Between Arm Change in IgG4 From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

5.  Secondary:   Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)   [ Time Frame: Baseline to end of dose build-up (up to 16 weeks) ]

6.  Secondary:   Between Arm Change in IgE From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Between Arm Change in IgE From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Robert A. Wood, MD
Organization: Johns Hopkins University
phone: 410-955-5883
e-mail: rwood@jhmi.edu


Publications of Results:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01084174     History of Changes
Other Study ID Numbers: NA_00032256
Study First Received: March 8, 2010
Results First Received: February 23, 2017
Last Updated: February 23, 2017