Trial Outcomes & Findings for Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy (NCT NCT00200850)
NCT ID: NCT00200850
Last Updated: 2019-06-12
Results Overview
Antigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units.
COMPLETED
NA
31 participants
baseline and after 12-18 months treatment
2019-06-12
Participant Flow
Out of 31 participants enrolled, 6 participants withdrew due to non-treatment-ascribed-event, 4 participants withdrew due to treatment-ascribed-events. Only 21 participants completed the study.
Participant milestones
| Measure |
Low Dose
Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily
|
High Dose
High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily
|
Placebo
Placebo
Placebo SLIT: Placebo SLIT daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
6
|
Reasons for withdrawal
| Measure |
Low Dose
Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily
|
High Dose
High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily
|
Placebo
Placebo
Placebo SLIT: Placebo SLIT daily
|
|---|---|---|---|
|
Overall Study
relocation
|
1
|
0
|
1
|
|
Overall Study
too busy
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Poor adherence
|
0
|
0
|
1
|
|
Overall Study
optic neuritis
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
Baseline Characteristics
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Baseline characteristics by cohort
| Measure |
Low Dose
n=10 Participants
Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily
|
High Dose
n=10 Participants
High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily
|
Placebo
n=11 Participants
Placebo
Placebo SLIT: Placebo SLIT daily
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 5.088 • n=93 Participants
|
33.8 years
STANDARD_DEVIATION 7.359 • n=4 Participants
|
29.3 years
STANDARD_DEVIATION 8.634 • n=27 Participants
|
30.6 years
STANDARD_DEVIATION 7.559 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: baseline and after 12-18 months treatmentAntigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units.
Outcome measures
| Measure |
Low Dose
n=7 Participants
Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily
|
High Dose
n=9 Participants
High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily
|
Placebo
n=5 Participants
Placebo
Placebo SLIT: Placebo SLIT daily
|
|---|---|---|---|
|
Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment
Baseline dose of antigen
|
75.0 cumulative breath units
Standard Deviation 56.7
|
69.5 cumulative breath units
Standard Deviation 46.8
|
141.4 cumulative breath units
Standard Deviation 147
|
|
Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment
Post treatment dose of antigen
|
74.8 cumulative breath units
Standard Deviation 57.3
|
100.9 cumulative breath units
Standard Deviation 35.2
|
83.3 cumulative breath units
Standard Deviation 59.3
|
Adverse Events
Low Dose
High Dose
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=10 participants at risk
Low dose SLIT
Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily
|
High Dose
n=10 participants at risk
High dose SLIT
High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily
|
Placebo
n=11 participants at risk
Placebo
Placebo SLIT: Placebo SLIT daily
|
|---|---|---|---|
|
General disorders
oral lesion
|
20.0%
2/10 • Number of events 2 • Up to 18 months
|
10.0%
1/10 • Number of events 3 • Up to 18 months
|
36.4%
4/11 • Number of events 5 • Up to 18 months
|
|
General disorders
throat irritation
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
20.0%
2/10 • Number of events 3 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
40.0%
4/10 • Number of events 6 • Up to 18 months
|
70.0%
7/10 • Number of events 17 • Up to 18 months
|
54.5%
6/11 • Number of events 9 • Up to 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • Up to 18 months
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
0.00%
0/11 • Up to 18 months
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
30.0%
3/10 • Number of events 3 • Up to 18 months
|
30.0%
3/10 • Number of events 5 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
10.0%
1/10 • Number of events 2 • Up to 18 months
|
18.2%
2/11 • Number of events 3 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Head cold
|
20.0%
2/10 • Number of events 2 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Up to 18 months
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
0.00%
0/11 • Up to 18 months
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 2 • Up to 18 months
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
20.0%
2/10 • Number of events 3 • Up to 18 months
|
30.0%
3/10 • Number of events 6 • Up to 18 months
|
36.4%
4/11 • Number of events 4 • Up to 18 months
|
|
Reproductive system and breast disorders
Reproductive issues
|
30.0%
3/10 • Number of events 3 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
0.00%
0/11 • Up to 18 months
|
|
Eye disorders
Eye infection
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
40.0%
4/10 • Number of events 7 • Up to 18 months
|
0.00%
0/11 • Up to 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatologic issues
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
27.3%
3/11 • Number of events 4 • Up to 18 months
|
|
General disorders
Ear infection
|
0.00%
0/10 • Up to 18 months
|
20.0%
2/10 • Number of events 2 • Up to 18 months
|
0.00%
0/11 • Up to 18 months
|
|
General disorders
Fatigue
|
0.00%
0/10 • Up to 18 months
|
10.0%
1/10 • Number of events 1 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
General disorders
Optic neuritis
|
0.00%
0/10 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
General disorders
Pain due to wisdom teeth extraction
|
0.00%
0/10 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
|
General disorders
Muffled hearing
|
0.00%
0/10 • Up to 18 months
|
0.00%
0/10 • Up to 18 months
|
9.1%
1/11 • Number of events 1 • Up to 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place