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Trial record 1 of 7 for:    "Cow Milk Allergy" | "Immunoglobulins"
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OIT and Xolair® (Omalizumab) in Cow's Milk Allergy

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ClinicalTrials.gov Identifier: NCT01157117
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : April 6, 2016
Last Update Posted : February 8, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Milk Allergy
Interventions Biological: Placebo for omalizumab
Biological: Omalizumab
Drug: Milk powder
Enrollment 77
Recruitment Details Recruitment took place at three university-based medical centers in the United States (Mount Sinai, Johns Hopkins University, Stanford University) beginning in October 2010. Accrual of randomized participants was completed in April 2012 and of untreated controls was completed in August 2012.
Pre-assignment Details  
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Period Title: Overall Study
Started 28 29 20
Began Omalizumab or Placebo Dosing 27 28 0
Began Milk OIT Dosing at Month 4 27 28 0
Reached Milk OIT Maintenance Dosing 26 26 0
Unblinded at Month 16 26 26 0
Completed Month 28 Desensitization OFC 26 24 0
Discontinued Milk OIT at Month 30 24 20 0
Completed Month 32 Tolerance OFC 24 20 0
Completed Final Month 38 Study Visit 19 18 3
Completed 19 [1] 18 [1] 5 [1]
Not Completed 9 11 15
Reason Not Completed
Dosing Symptoms             0             4             0
Withdrawal by Subject             4             1             1
Lack of Efficacy             1             1             0
Lost to Follow-up             0             0             1
Unknown (Pending Final Form Submission)             4             5             13
[1]
Completed final study visit at Month 38, 6 months after final Month 32 OFC.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control Total
Hide Arm/Group Description Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. Total of all reporting groups
Overall Number of Baseline Participants 28 29 20 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 20 participants 77 participants
<=18 years
26
  92.9%
27
  93.1%
20
 100.0%
73
  94.8%
Between 18 and 65 years
2
   7.1%
2
   6.9%
0
   0.0%
4
   5.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 20 participants 77 participants
Female
8
  28.6%
9
  31.0%
5
  25.0%
22
  28.6%
Male
20
  71.4%
20
  69.0%
15
  75.0%
55
  71.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 20 participants 77 participants
Hispanic or Latino origin 0 2 0 2
Non-Hispanic or non-Latino origin 28 27 20 75
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 20 participants 77 participants
Asian 4 3 2 9
Black/African American 1 0 0 1
White 23 26 18 67
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 29 participants 20 participants 77 participants
28 29 20 77
Age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 20 participants 77 participants
12.6  (4.1) 11.5  (5.6) 11.3  (2.9) 11.8  (4.5)
Atopic Dermatitis Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 28 participants 29 participants 20 participants 77 participants
0.3  (0.9) 0.5  (1.5) 1.0  (2.3) 0.5  (1.5)
[1]
Measure Description: The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity. Note: These data were only available for 12 of the 20 Untreated Control participants.
Total IgE   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 28 participants 29 participants 20 participants 77 participants
683.1  (658.9) 686.6  (565.7) 878.8  (824.3) 735.2  (670.3)
[1]
Measure Description: Total amount of serum immunoglobulin E (IgE).
Milk IgE   [1] 
Mean (Standard Deviation)
Unit of measure:  kUA/L
Number Analyzed 28 participants 29 participants 20 participants 77 participants
52.2  (47.4) 57.9  (55.5) 72.4  (63.9) 59.6  (54.9)
[1]
Measure Description: Amount of serum milk-specific immunoglobulin E (IgE). Individuals with a milk IgE of <0.35 kUA/L (allergen-equivalent kilounits per liter) are considered not to be sensitized to milk.
Milk Skin Prick Test Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 28 participants 29 participants 20 participants 77 participants
8.9  (3.3) 9.0  (3.2) NA [2]   (NA) 8.9  (3.2)
[1]
Measure Description: This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the milk wheal (in mm) observed for a skin prick test. Individuals with a milk skin prick test score of < 3 mm are considered to have a negative result.
[2]
Data were not collected for this group.
Age at Initial Milk Allergic Reaction   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 20 participants 77 participants
0.9  (1.8) 0.5  (0.5) 0.9  (0.8) 0.7  (1.1)
[1]
Measure Description: Age in years at the participant's first milk allergic reaction. Note: These data were only available for 14 of the 28 Omalizumab/Milk OIT participants, 19 of the 29 Placebo for Omalizumab/Milk OIT participants, and 14 of the 20 Untreated Control participants.
1.Primary Outcome
Title Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk
Hide Description Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.
Time Frame Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 28 29
Measure Type: Number
Unit of Measure: Percent of participants
46.4 34.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omalizumab/Milk OIT, Placebo for Omalizumab/Milk OIT
Comments Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher’s Exact test with the null hypothesis that there was no difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments No adjustments were made to the p-value.
Method Fisher Exact
Comments The a priori threshold for statistical significance is 0.05.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
-13.4 to 37.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Dosing Reactions to Milk OIT During the Escalation Phase
Hide Description Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.
Time Frame Baseline to completion of Escalation Phase at 22 to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received any milk OIT dosing during the Escalation Phase.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: percentage of participants
81.5 96.4
3.Secondary Outcome
Title Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase
Hide Description Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.
Time Frame After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received milk OIT dosing during the Maintenance Phase.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 26 26
Measure Type: Number
Unit of Measure: percentage of participants
46.2 96.2
4.Secondary Outcome
Title Incidence of Severe Hypersensitivity Reactions to Milk OIT
Hide Description Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.
Time Frame Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received milk OIT dosing.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: percentage of participants
0 0
5.Secondary Outcome
Title Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)
Hide Description Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Time Frame Baseline to completion of Escalation Phase at 22 to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received any milk OIT dosing
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: mg milk powder
9941.7  (2692.9) 9174.0  (3344.6)
6.Secondary Outcome
Title Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk
Hide Description Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.
Time Frame Month 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received any study treatment
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: percentage of participants
88.9 71.4
7.Secondary Outcome
Title Time to Maximum Tolerated Dose
Hide Description Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Time Frame Baseline to completion of Escalation Phase at 22 to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test
Hide Description A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.
Time Frame Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Overall Number of Participants Analyzed 25 22
Median (Full Range)
Unit of Measure: units on a scale
-12.5
(-32.0 to 3.0)
-15.3
(-45.0 to -1.5)
9.Secondary Outcome
Title Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)
Hide Description The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Time Frame Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 25 22 6
Median (Full Range)
Unit of Measure: kUA/L
Change in Milk IgE
-9.8
(-134.2 to 50.5)
-16.9
(-121.7 to 200.0)
0.8
(-78.4 to 103.4)
Change in Casein IgE
-6.2
(-194.1 to 596.0)
-27.7
(-170.6 to 69.0)
3.5
(-76.1 to 177.2)
Change in Beta-lactoglobulin IgE
-1.7
(-72.5 to 59.1)
-2.9
(-129.5 to 41.6)
7.2
(-33.7 to 41.7)
10.Secondary Outcome
Title Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)
Hide Description Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Time Frame Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 25 22 6
Median (Full Range)
Unit of Measure: mgA/L
Change in Casein IgG4
17.3
(0.2 to 57.2)
13.5
(-0.2 to 47.4)
0.1
(-0.3 to 60.4)
Change in Beta-lactoglobulin IgG4
24.9
(-0.1 to 58.7)
20.8
(-0.1 to 62.3)
-0.02
(-1.3 to 52.5)
11.Secondary Outcome
Title Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)
Hide Description The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Time Frame Month 38
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 18 18 5
Median (Full Range)
Unit of Measure: kUA/L
Change in Milk IgE
-25.1
(-135.6 to 37.0)
-15.8
(-147.5 to 18.1)
-1.0
(-8.3 to 95.4)
Change in Casein IgE
-14.9
(-194.8 to 58.0)
-34.8
(-189.5 to 7.4)
1.6
(-0.6 to 71.2)
Change in Beta-lactoglobulin IgE
-2.7
(-73.8 to 68.1)
-2.6
(-139.2 to 91.1)
1.9
(-13.1 to 28.0)
12.Secondary Outcome
Title Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)
Hide Description Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Time Frame Month 38
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 18 18 5
Median (Full Range)
Unit of Measure: mgA/L
Change in Casein IgG4
44.9
(0.6 to 100.3)
21.0
(-1.5 to 56.5)
0.4
(-0.6 to 16.6)
Change in Beta-lactoglobulin IgG4
23.8
(0.1 to 121.5)
25.6
(-2.6 to 125.0)
-0.02
(-0.7 to 0.3)
13.Secondary Outcome
Title Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk
Hide Description Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.
Time Frame Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 21 19 5
Median (Full Range)
Unit of Measure: percentage of CD63+ basophils
Change in %CD63+ for 10 µg/mL stimulant
11.1
(-19.8 to 81.2)
8.7
(-61.4 to 76.0)
13.0
(10.3 to 25.5)
Change in %CD63+ for 1 µg/mL stimulant
7.5
(-37.3 to 74.2)
0.6
(-56.6 to 85.2)
6.9
(-2.6 to 40.9)
Change in %CD63+ for 0.1 µg/mL stimulant
-11.8
(-57.3 to 34.2)
-5.5
(-53.2 to 79.1)
15.9
(-7.3 to 45.9)
Change in %CD63+ for 0.01 µg/mL stimulant
-6.5
(-47.5 to 23.2)
-3.8
(-59.2 to 87.6)
26.2
(-4.7 to 35.5)
Change in %CD63+ for 0.001 µg/mL stimulant
-1.3
(-41.5 to 19.1)
-1.2
(-44.0 to 85.5)
1.9
(-1.7 to 7.5)
14.Secondary Outcome
Title Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk
Hide Description Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.
Time Frame Month 38
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description:
Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
Overall Number of Participants Analyzed 19 18 5
Median (Full Range)
Unit of Measure: percentage of CD63+ basophils
Change in %CD63+ for 10 µg/mL stimulant
-9.2
(-59.3 to 56.6)
-11.7
(-72.9 to 46.1)
26.7
(14.0 to 53.0)
Change in %CD63+ for 1 µg/mL stimulant
-8.2
(-53.1 to 17.2)
-9.5
(-57.5 to 57.7)
29.5
(-0.2 to 37.8)
Change in %CD63+ for 0.1 µg/mL stimulant
-18.6
(-59.4 to 1.8)
-21.6
(-63.0 to 0.0)
28.6
(17.2 to 42.2)
Change in %CD63+ for 0.01 µg/mL stimulant
-10.2
(-61.9 to 0.5)
-7.8
(-64.5 to 8.5)
8.4
(-10.1 to 36.2)
Change in %CD63+ for 0.001 µg/mL stimulant
-5.2
(-59.3 to 0.8)
-4.0
(-43.7 to 3.6)
1.6
(-2.2 to 39.6)
Time Frame Adverse Events were reported through the end of the study.
Adverse Event Reporting Description Other [Not Including Serious] Adverse Events in the Untreated Control Arm were reported only in the 72 hours after any study-specific blood draws.
 
Arm/Group Title Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Hide Arm/Group Description Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight). Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
All-Cause Mortality
Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      0/29 (0.00%)      1/20 (5.00%)    
Infections and infestations       
Abscess * 1  1/28 (3.57%)  1 0/29 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/28 (0.00%)  0 0/29 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omalizumab/Milk OIT Placebo for Omalizumab/Milk OIT Untreated Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/28 (92.86%)      28/29 (96.55%)      1/20 (5.00%)    
Ear and labyrinth disorders       
Ear Pruritus  1  1/27 (3.70%)  1 3/28 (10.71%)  102 0/20 (0.00%)  0
Eye disorders       
Conjunctivitis * 1  2/28 (7.14%)  2 0/29 (0.00%)  0 0/20 (0.00%)  0
Eye Pruritus  1  3/27 (11.11%)  3 6/28 (21.43%)  11 0/20 (0.00%)  0
Ocular hyperaemia  1  1/27 (3.70%)  1 2/28 (7.14%)  2 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain * 1  0/28 (0.00%)  0 2/29 (6.90%)  3 0/20 (0.00%)  0
Vomiting * 1  4/28 (14.29%)  5 1/29 (3.45%)  1 0/20 (0.00%)  0
Abdominal Discomfort  1  12/27 (44.44%)  112 25/28 (89.29%)  531 0/20 (0.00%)  0
Abdominal Distension  1  0/27 (0.00%)  0 2/28 (7.14%)  38 0/20 (0.00%)  0
Abdominal Pain  1  3/27 (11.11%)  12 8/28 (28.57%)  21 0/20 (0.00%)  0
Diarrhoea  1  5/27 (18.52%)  10 3/28 (10.71%)  7 0/20 (0.00%)  0
Dyspepsia  1  2/27 (7.41%)  4 5/28 (17.86%)  75 0/20 (0.00%)  0
Dysphagia  1  0/27 (0.00%)  0 2/28 (7.14%)  4 0/20 (0.00%)  0
Nausea  1  2/27 (7.41%)  12 6/28 (21.43%)  9 0/20 (0.00%)  0
Oral Disorder  1  19/27 (70.37%)  373 27/28 (96.43%)  2441 0/20 (0.00%)  0
Vomiting  1  7/27 (25.93%)  21 11/28 (39.29%)  20 0/20 (0.00%)  0
General disorders       
Influenza like illness * 1  0/28 (0.00%)  0 3/29 (10.34%)  3 0/20 (0.00%)  0
Pain * 1  3/28 (10.71%)  3 1/29 (3.45%)  1 0/20 (0.00%)  0
Pyrexia * 1  6/28 (21.43%)  6 9/29 (31.03%)  11 0/20 (0.00%)  0
Chest Discomfort  1  3/27 (11.11%)  6 16/28 (57.14%)  225 0/20 (0.00%)  0
Chest Pain  1  2/27 (7.41%)  3 4/28 (14.29%)  7 0/20 (0.00%)  0
Feeling Abnormal  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/20 (0.00%)  0
Sensation of foreign body  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/20 (0.00%)  0
Immune system disorders       
Anaphylactic Reaction * 1  1/28 (3.57%)  1 2/29 (6.90%)  2 0/20 (0.00%)  0
Infections and infestations       
Ear Infection * 1  3/28 (10.71%)  6 4/29 (13.79%)  5 0/20 (0.00%)  0
Furuncle * 1  2/28 (7.14%)  2 0/29 (0.00%)  0 0/20 (0.00%)  0
Gastroenteritis * 1  1/28 (3.57%)  1 5/29 (17.24%)  6 0/20 (0.00%)  0
Gastroenteritis viral * 1  9/28 (32.14%)  14 10/29 (34.48%)  13 0/20 (0.00%)  0
Gastrointestinal viral infection * 1  0/28 (0.00%)  0 2/29 (6.90%)  2 0/20 (0.00%)  0
Impetigo * 1  3/28 (10.71%)  3 0/29 (0.00%)  0 0/20 (0.00%)  0
Influenza * 1  2/28 (7.14%)  2 7/29 (24.14%)  8 0/20 (0.00%)  0
Nasopharyngitis * 1  6/28 (21.43%)  7 6/29 (20.69%)  8 0/20 (0.00%)  0
Otitis media * 1  2/28 (7.14%)  2 0/29 (0.00%)  0 0/20 (0.00%)  0
Pharyngitis streptococcal * 1  5/28 (17.86%)  7 4/29 (13.79%)  6 0/20 (0.00%)  0
Sinusitis * 1  7/28 (25.00%)  11 5/29 (17.24%)  9 0/20 (0.00%)  0
Upper respiratory tract infection * 1  12/28 (42.86%)  17 12/29 (41.38%)  22 0/20 (0.00%)  0
Viral upper respiratory tract infection * 1  2/28 (7.14%)  9 1/29 (3.45%)  1 0/20 (0.00%)  0
Nasopharyngitis  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod bite * 1  2/28 (7.14%)  2 1/29 (3.45%)  1 0/20 (0.00%)  0
Foot fracture * 1  2/28 (7.14%)  2 1/29 (3.45%)  1 0/20 (0.00%)  0
Joint injury * 1  1/28 (3.57%)  1 4/29 (13.79%)  4 0/20 (0.00%)  0
Investigations       
Blood bilirubin increased * 1  2/28 (7.14%)  2 0/29 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  4/28 (14.29%)  5 8/29 (27.59%)  15 1/20 (5.00%)  1
Cough * 1  3/28 (10.71%)  3 2/29 (6.90%)  2 0/20 (0.00%)  0
Oropharyngeal pain * 1  2/28 (7.14%)  2 0/29 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory tract congestion * 1  1/28 (3.57%)  1 2/29 (6.90%)  2 0/20 (0.00%)  0
Wheezing * 1  1/28 (3.57%)  1 2/29 (6.90%)  2 0/20 (0.00%)  0
Cough  1  5/27 (18.52%)  11 14/28 (50.00%)  149 0/20 (0.00%)  0
Dysphonia  1  0/27 (0.00%)  0 2/28 (7.14%)  5 0/20 (0.00%)  0
Dyspnoea  1  2/27 (7.41%)  3 10/28 (35.71%)  43 0/20 (0.00%)  0
Oropharyngeal discomfort  1  11/27 (40.74%)  85 22/28 (78.57%)  202 0/20 (0.00%)  0
Sinus congestion  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/20 (0.00%)  0
Nasal congestion  1  6/27 (22.22%)  12 15/28 (53.57%)  102 0/20 (0.00%)  0
Sneezing  1  6/27 (22.22%)  15 22/28 (78.57%)  155 0/20 (0.00%)  0
Throat tightness  1  2/27 (7.41%)  2 9/28 (32.14%)  12 0/20 (0.00%)  0
Wheezing  1  3/27 (11.11%)  5 12/28 (42.86%)  28 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Eczema * 1  2/28 (7.14%)  2 1/29 (3.45%)  8 0/20 (0.00%)  0
Rash * 1  2/28 (7.14%)  3 1/29 (3.45%)  1 0/20 (0.00%)  0
Urticaria * 1  0/28 (0.00%)  0 2/29 (6.90%)  2 0/20 (0.00%)  0
Pruritus  1  10/27 (37.04%)  28 20/28 (71.43%)  264 0/20 (0.00%)  0
Rash  1  0/27 (0.00%)  0 5/28 (17.86%)  34 0/20 (0.00%)  0
Urticaria  1  8/27 (29.63%)  47 23/28 (82.14%)  167 0/20 (0.00%)  0
Vascular disorders       
Flushing  1  4/27 (14.81%)  5 16/28 (57.14%)  92 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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
Layout table for Results Point of Contact information
Name/Title: Dr. Hugh A. Sampson
Organization: Ichan School of Medicine at Mount Sinai
Phone: 212-659-9426
EMail: hugh.sampson@mssm.edu
Layout table for additonal information
Responsible Party: Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01157117     History of Changes
Other Study ID Numbers: DAIT AADCRC-MSSM-01
U19AI044236 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2010
First Posted: July 5, 2010
Results First Submitted: January 5, 2016
Results First Posted: April 6, 2016
Last Update Posted: February 8, 2017