Trial Outcomes & Findings for The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults (NCT NCT01822353)
NCT ID: NCT01822353
Last Updated: 2021-02-11
Results Overview
Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
One year
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
Milk Allergy
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk oral immunotherapy
|
Nut Allergy
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Nut oral immunotherapy
|
Egg Allergy
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Egg oral immunotherapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
1
|
Reasons for withdrawal
| Measure |
Milk Allergy
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk oral immunotherapy
|
Nut Allergy
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Nut oral immunotherapy
|
Egg Allergy
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Egg oral immunotherapy
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
4 participants
n=4 Participants
|
23 participants
n=23 Participants
|
|
Allergen specific IgE
|
57.8 kU/l
STANDARD_DEVIATION 60.4 • n=10 Participants
|
48.8 kU/l
STANDARD_DEVIATION 104.1 • n=9 Participants
|
22.4 kU/l
STANDARD_DEVIATION 15.5 • n=4 Participants
|
47.7 kU/l
STANDARD_DEVIATION 75.6 • n=23 Participants
|
PRIMARY outcome
Timeframe: One yearNumber of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy
|
6 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: One yearDoes hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Effect of Therapy on Lung Function.
FEV1 (%) before OIT
|
91.4 percentage of predicted value
Standard Deviation 7.4
|
96.1 percentage of predicted value
Standard Deviation 13.8
|
86.1 percentage of predicted value
Standard Deviation 8.9
|
|
Effect of Therapy on Lung Function.
FEV1 (%) OIT
|
92.1 percentage of predicted value
Standard Deviation 6.0
|
96.3 percentage of predicted value
Standard Deviation 7.4
|
84.0 percentage of predicted value
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: One yearPopulation: Drop out in the number of study individuals in the methacholine measurements at one year after OIT
Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Does Oral Immunotherapy Change Bronchial Hyperreactivity?
After OIT
|
615.5 Dose of methcholine, ug
Standard Deviation 0.0
|
2059.0 Dose of methcholine, ug
Standard Deviation 0.0
|
973.4 Dose of methcholine, ug
Standard Deviation 1029.1
|
|
Does Oral Immunotherapy Change Bronchial Hyperreactivity?
Before OIT
|
531.3 Dose of methcholine, ug
Standard Deviation 696.1
|
1303.9 Dose of methcholine, ug
Standard Deviation 1589.0
|
691.2 Dose of methcholine, ug
Standard Deviation 507.4
|
SECONDARY outcome
Timeframe: One yearDoes the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?
Before OIT
|
45.3 ppb
Standard Deviation 36.7
|
25.7 ppb
Standard Deviation 19.2
|
66.6 ppb
Standard Deviation 51.3
|
|
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?
After OIT
|
22.5 ppb
Standard Deviation 18.9
|
25.7 ppb
Standard Deviation 18.1
|
66.2 ppb
Standard Deviation 60.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearHow many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.
Mild side effects
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.
Moderate side effects
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.
Severe side effects
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.
Quitting because of side effects
|
1 Participants
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearPopulation: Drop out in answers for quality of life at one year after OIT
Quality of life is assessed by a questionnaire before and after immunotherapy (VAS scale on worries on allergy 0-100, 0 no worries, 100 maximal worries).
Outcome measures
| Measure |
Milk Allergy
n=10 Participants
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 Participants
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 Participants
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Effect of Treatment on Quality of Life
Before OIT
|
83.9 VAS score (mm)
Standard Deviation 15.1
|
63.5 VAS score (mm)
Standard Deviation 23.3
|
61.0 VAS score (mm)
Standard Deviation 13.0
|
|
Effect of Treatment on Quality of Life
After OIT
|
73.0 VAS score (mm)
Standard Deviation 5.0
|
—
|
—
|
Adverse Events
Milk Allergy
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Nut Allergy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Egg Allergy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Milk Allergy
n=10 participants at risk
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 participants at risk
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 participants at risk
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Immune system disorders
Systemic allergic reaction
|
20.0%
2/10 • 4 years
|
11.1%
1/9 • 4 years
|
0.00%
0/4 • 4 years
|
Other adverse events
| Measure |
Milk Allergy
n=10 participants at risk
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Nut Allergy
n=9 participants at risk
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
Egg Allergy
n=4 participants at risk
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary supplement: Milk, egg or nut oral immunotherapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Mouth and throat itching
|
80.0%
8/10 • 4 years
|
66.7%
6/9 • 4 years
|
75.0%
3/4 • 4 years
|
Additional Information
Paula Kauppi, Chief Specialist
Helsinki University Hospital, Helsinki, Finland
Phone: +358504286802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place