A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00580606
First received: December 18, 2007
Last updated: May 23, 2013
Last verified: May 2013
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Food Hypersensitivity
Hypersensitivity
Immediate Hypersensitivity
Peanut Hypersensitivity
Interventions: Drug: Glycerinated peanut allergenic extract
Drug: Placebo for peanut extract (glycerin)

  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
Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital from April 2008 to January 2010.

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
Low Dose Peanut SLIT (Double Blind to Open Label) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.

Participant Flow for 2 periods

Period 1:   Double Blind (DB)
    Low Dose Peanut SLIT (Double Blind to Open Label)     Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)  
STARTED     20     20  
Had Week 44 Oral Food Challenge     18     19  
COMPLETED     20 [1]   20 [1]
NOT COMPLETED     0     0  
[1] Completed: Participants who were assessed for the primary outcome measure.

Period 2:   Open Label (OL)
    Low Dose Peanut SLIT (Double Blind to Open Label)     Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)  
STARTED     18 [1]   17 [2]
COMPLETED     2 [3]   0 [3]
NOT COMPLETED     16     17  
Currently Dosing                 8                 10  
Withdrawal by Subject                 5                 3  
Lack of Efficacy                 2                 0  
Physician Decision                 1                 1  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  
Pregnancy                 0                 1  
[1] 2 participants discontinued dosing before Week 44 OFC.
[2] 1 participant discontinued dosing before Wk 44 OFC; 2 passed Wk 44 OFC & ineligible for crossover.
[3] Completed: Participants who have completed dosing and final OFC.



  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
Low Dose Peanut SLIT (Double Blind to Open Label) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
Total Total of all reporting groups

Baseline Measures
    Low Dose Peanut SLIT (Double Blind to Open Label)     Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     15     15     30  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  17.2  ± 7.6     16.5  ± 3.5     16.8  ± 5.8  
Gender  
[units: participants]
     
Female     7     6     13  
Male     13     14     27  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     20     20     40  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     17     19     36  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  
Atopic Dermatitis Total Score [1]
[units: Scores on a scale]
Mean ± Standard Deviation
  1.1  ± 1.7     0.9  ± 1.6     1.0  ± 1.6  
Total IgE [2]
[units: kU/L]
Mean ± Standard Deviation
  407.8  ± 254.1     330.5  ± 305.0     369.1  ± 279.9  
Peanut IgE [3]
[units: kUA/L]
Mean ± Standard Deviation
  33.6  ± 38.1     47.1  ± 58.0     40.4  ± 48.9  
Peanut Skin Prick Test Score [4]
[units: mm]
Mean ± Standard Deviation
  14.0  ± 6.9     12.4  ± 4.6     13.2  ± 5.9  
Age at Initial Peanut Allergic Reaction [5]
[units: years]
Mean ± Standard Deviation
  4.6  ± 6.9     1.9  ± 1.5     3.3  ± 5.2  
[1] 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.
[2] Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L.
[3] Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of <0.35 kUA/L are considered not to be sensitized to peanut.
[4] This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of < 3 mm are considered to have a negative result. 1 subject in the Placebo group did not have a value for this measure.
[5] Two subjects in the Placebo group did not have a value for this measure.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge   [ Time Frame: Week 44 (Double Blind Period) ]

2.  Secondary:   Percent of Participants Who Achieved a Maintenance Dose of 1,386 Mcg   [ Time Frame: Week 44 (Double Blind Period) ]

3.  Secondary:   Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption   [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ]

4.  Secondary:   Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 Mcg   [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ]

5.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Baseline through Week 44 (Double Blind Period) ]

6.  Secondary:   Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption   [ Time Frame: Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption ]

7.  Secondary:   Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder   [ Time Frame: Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Baseline through 44 weeks of study therapy
Additional Description This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Low Dose Peanut SLIT (Double Blind) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
Placebo (Double Blind) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
High Dose Peanut SLIT Crossover (Open Label) Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.

Other Adverse Events
    Low Dose Peanut SLIT (Double Blind)     Placebo (Double Blind)     High Dose Peanut SLIT Crossover (Open Label)  
Total, other (not including serious) adverse events        
# participants affected / at risk     19/20     20/20     17/17  
Ear and labyrinth disorders        
Ear pruritus † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     0     1     114  
Vertigo * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Eye disorders        
Conjunctivitis allergic * 1      
# participants affected / at risk     2/20 (10.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     2     1     0  
Conjunctivitis * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     0     1     1  
Eye pruritus † 1      
# participants affected / at risk     1/20 (5.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     1     2     0  
Photophobia * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Gastrointestinal disorders        
Abdominal discomfort * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Abdominal discomfort † 2      
# participants affected / at risk     3/20 (15.00%)     0/20 (0.00%)     3/17 (17.65%)  
# events     8     0     22  
Abdominal pain upper * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     2/17 (11.76%)  
# events     0     0     2  
Abdominal pain upper † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     2     0     0  
Abdominal pain * 1      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     3     0     0  
Abdominal pain † 2      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Dental discomfort * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Diarrhoea * 1      
# participants affected / at risk     0/20 (0.00%)     3/20 (15.00%)     0/17 (0.00%)  
# events     0     4     0  
Dyspepsia † 1      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     3     0     0  
Enterocolitis * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Gastrooesophageal reflux disease * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Lip pruritus † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Lip swelling * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Lip swelling † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     6     0     0  
Lip ulceration * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Mouth ulceration * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     0     1     1  
Nausea * 1      
# participants affected / at risk     1/20 (5.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     1     1     0  
Nausea † 1      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     10     0     1  
Oral disorder † 2      
# participants affected / at risk     17/20 (85.00%)     6/20 (30.00%)     16/17 (94.12%)  
# events     2098     22     1514  
Oral pain * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Oral pruritus † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     2     0     0  
Palatal disorder † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Salivary hypersecretion † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     52     0     0  
Swollen tongue † 1      
# participants affected / at risk     3/20 (15.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     6     0     1  
Toothache * 1      
# participants affected / at risk     0/20 (0.00%)     2/20 (10.00%)     0/17 (0.00%)  
# events     0     2     0  
Vomiting * 1      
# participants affected / at risk     0/20 (0.00%)     2/20 (10.00%)     2/17 (11.76%)  
# events     0     2     2  
General disorders        
Adverse drug reaction * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Chest pain † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Chills † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     2     0     0  
Fatigue † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     3     0  
Feeling hot † 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Hunger † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Influenza like illness * 1      
# participants affected / at risk     1/20 (5.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     1     1     1  
Pain * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Pyrexia * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     1     0     2  
Immune system disorders        
Allergy to animal * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Otitis media * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     1     0     1  
Infections and infestations        
Bronchitis * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Cat scratch disease * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Cystitis * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Ear infection * 1      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     3     0     0  
Eye infection * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Febrile infection * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     2     0  
Gastroenteritis viral * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Gastroenteritis * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     0     1     1  
Gastrointestinal viral infection * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Hordeolum * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Influenza * 1      
# participants affected / at risk     1/20 (5.00%)     2/20 (10.00%)     2/17 (11.76%)  
# events     1     2     2  
Lyme disease * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Meningitis viral * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Nasopharyngitis * 1      
# participants affected / at risk     4/20 (20.00%)     5/20 (25.00%)     3/17 (17.65%)  
# events     6     7     7  
Otitis externa * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Pharyngitis streptococcal * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Respiratory tract infection * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Rhinitis * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Sinusitis * 1      
# participants affected / at risk     4/20 (20.00%)     2/20 (10.00%)     3/17 (17.65%)  
# events     5     2     4  
Tonsillitis * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Upper respiratory tract infection * 1      
# participants affected / at risk     4/20 (20.00%)     4/20 (20.00%)     3/17 (17.65%)  
# events     5     8     6  
Urinary tract infection * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Viral infection * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Wound infection * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Injury, poisoning and procedural complications        
Arthropod bite * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Concussion * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Excoriation * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Eye injury * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Head injury * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Joint injury * 1      
# participants affected / at risk     1/20 (5.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     1     1     0  
Laceration * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Ligament injury * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Ligament sprain * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Lip injury * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Lower limb fracture * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Pelvic fracture * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Procedural pain * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Road traffic accident * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Investigations        
Ear, nose and throat examination abnormal * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Musculoskeletal and connective tissue disorders        
Arthralgia * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Back pain * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Neck pain * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Pain in extremity * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Pain in jaw * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Tendonitis * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Nervous system disorders        
Dizziness * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Dizziness † 1      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     4     0     0  
Headache * 1      
# participants affected / at risk     2/20 (10.00%)     3/20 (15.00%)     3/17 (17.65%)  
# events     4     5     6  
Paraesthesia † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Sinus headache * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     2     0  
Sinus headache † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Pregnancy, puerperium and perinatal conditions        
Pregnancy * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Psychiatric disorders        
Anxiety † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Insomnia † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Restlessness † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Reproductive system and breast disorders        
Dysmenorrhoea * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     3     0     1  
Respiratory, thoracic and mediastinal disorders        
Asthma * 1      
# participants affected / at risk     0/20 (0.00%)     2/20 (10.00%)     2/17 (11.76%)  
# events     0     2     3  
Cough * 1      
# participants affected / at risk     2/20 (10.00%)     1/20 (5.00%)     2/17 (11.76%)  
# events     2     1     2  
Cough † 2      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     56     0     0  
Dyspnoea * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Dyspnoea † 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Increased upper airway secretion † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     2     0     0  
Nasal congestion * 1      
# participants affected / at risk     1/20 (5.00%)     2/20 (10.00%)     0/17 (0.00%)  
# events     1     4     0  
Nasal congestion † 2      
# participants affected / at risk     2/20 (10.00%)     1/20 (5.00%)     1/17 (5.88%)  
# events     2     1     2  
Oropharyngeal discomfort † 2      
# participants affected / at risk     3/20 (15.00%)     2/20 (10.00%)     1/17 (5.88%)  
# events     3     3     1  
Oropharyngeal pain * 1      
# participants affected / at risk     3/20 (15.00%)     2/20 (10.00%)     1/17 (5.88%)  
# events     3     3     1  
Respiratory tract congestion * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Rhinalgia † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Rhinitis allergic * 1      
# participants affected / at risk     1/20 (5.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     1     1     0  
Rhinorrhoea † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Sinus congestion * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Sneezing † 2      
# participants affected / at risk     2/20 (10.00%)     0/20 (0.00%)     3/17 (17.65%)  
# events     3     0     6  
Throat irritation † 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     2     0     1  
Upper respiratory tract congestion * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     4/17 (23.53%)  
# events     0     1     4  
Wheezing * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     2  
Wheezing † 2      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Skin and subcutaneous tissue disorders        
Angioedema † 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Dermatitis contact * 1      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     2/17 (11.76%)  
# events     1     0     3  
Pruritus † 1      
# participants affected / at risk     4/20 (20.00%)     2/20 (10.00%)     1/17 (5.88%)  
# events     56     5     1  
Rash † 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Urticaria * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     2/17 (11.76%)  
# events     0     0     2  
Urticaria † 2      
# participants affected / at risk     2/20 (10.00%)     1/20 (5.00%)     4/17 (23.53%)  
# events     9     1     9  
Surgical and medical procedures        
Polypectomy * 1      
# participants affected / at risk     0/20 (0.00%)     1/20 (5.00%)     0/17 (0.00%)  
# events     0     1     0  
Tonsillectomy * 1      
# participants affected / at risk     0/20 (0.00%)     0/20 (0.00%)     1/17 (5.88%)  
# events     0     0     1  
Vascular disorders        
Flushing † 2      
# participants affected / at risk     1/20 (5.00%)     0/20 (0.00%)     0/17 (0.00%)  
# events     1     0     0  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (15.0)
2 Term from vocabulary, MedDRA (14.1)



  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: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsgov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00580606     History of Changes
Other Study ID Numbers: DAIT CoFAR4
Study First Received: December 18, 2007
Results First Received: September 28, 2012
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration