Trial Outcomes & Findings for Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents (NCT NCT01919554)
NCT ID: NCT01919554
Last Updated: 2025-01-17
Results Overview
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
10 dosing treatment days
Results posted on
2025-01-17
Participant Flow
First Patient First Visit 29 JUL 2013, Last Patient Last Visit 30 SEP 2013
Participant milestones
| Measure |
500 IR
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
500 IR
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
Baseline characteristics by cohort
| Measure |
500 IR
n=9 Participants
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
n=9 Participants
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
n=9 Participants
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
n=10 Participants
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.4 years
STANDARD_DEVIATION 1.33 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 1.45 • n=7 Participants
|
15.3 years
STANDARD_DEVIATION 1.12 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 1.78 • n=4 Participants
|
14.9 years
STANDARD_DEVIATION 1.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 dosing treatment daysPopulation: Safety Set: All patients who received at least one dose of treatment including those who did not complete the study were included in the Safety Set.
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Outcome measures
| Measure |
500 IR
n=9 Participants
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
n=9 Participants
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
n=9 Participants
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
n=10 Participants
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
|
4 participants
|
6 participants
|
9 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 10 dosing treatment daysTreatment emergent Serious Adverse Events
Outcome measures
| Measure |
500 IR
n=9 Participants
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
n=9 Participants
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
n=9 Participants
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
n=10 Participants
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Treatment Emergent Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 dosing treatment daysIncidence of adverse events leading to study withdrawal
Outcome measures
| Measure |
500 IR
n=9 Participants
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
n=9 Participants
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
n=9 Participants
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
n=10 Participants
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Adverse Events Leading to Study Withdrawal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
500 IR
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1000 IR
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1500 IR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
500 IR
n=9 participants at risk
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days
|
1000 IR
n=9 participants at risk
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days
|
1500 IR
n=9 participants at risk
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days
|
Placebo
n=10 participants at risk
Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
11.1%
1/9
|
44.4%
4/9
|
55.6%
5/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9
|
22.2%
2/9
|
22.2%
2/9
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9
|
22.2%
2/9
|
22.2%
2/9
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9
|
11.1%
1/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
11.1%
1/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Oral pruritus
|
11.1%
1/9
|
44.4%
4/9
|
33.3%
3/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Lip pruritus
|
11.1%
1/9
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Oedema mouth
|
22.2%
2/9
|
11.1%
1/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
10.0%
1/10
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
22.2%
2/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Tongue eruption
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Influenza like illness
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/10
|
|
General disorders
Chest discomfort
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
General disorders
Fatigue
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Ear pruritus
|
22.2%
2/9
|
11.1%
1/9
|
22.2%
2/9
|
0.00%
0/10
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Conjunctivitis allergic
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
20.0%
2/10
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place