Trial Outcomes & Findings for Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model (NCT NCT01527188)
NCT ID: NCT01527188
Last Updated: 2025-02-04
Results Overview
The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS\_0-4h. A decrease in the AUCRTSS\_0-4h value represents relief from the HDM allergic symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
355 participants
Primary outcome timeframe
6 months
Results posted on
2025-02-04
Participant Flow
First Patient First Visit 08 DEC 2010, Last Patient Last Visit 19 SEP 2012
Participant milestones
| Measure |
100 IR
100 IR house dust mites allergen extract tablet
|
300 IR
300 IR house dust mites allergen extract tablet
|
500 IR
500 IR house dust mites allergen extract tablet
|
Placebo
Placebo tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
86
|
93
|
87
|
|
Overall Study
COMPLETED
|
75
|
68
|
70
|
75
|
|
Overall Study
NOT COMPLETED
|
14
|
18
|
23
|
12
|
Reasons for withdrawal
| Measure |
100 IR
100 IR house dust mites allergen extract tablet
|
300 IR
300 IR house dust mites allergen extract tablet
|
500 IR
500 IR house dust mites allergen extract tablet
|
Placebo
Placebo tablet
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
11
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
4
|
4
|
|
Overall Study
Any other reason not above-mentioned
|
6
|
7
|
8
|
8
|
Baseline Characteristics
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model
Baseline characteristics by cohort
| Measure |
100 IR
n=89 Participants
100 IR house dust mites allergen extract tablet
|
300 IR
n=86 Participants
300 IR house dust mites allergen extract tablet
|
500 IR
n=93 Participants
500 IR house dust mites allergen extract tablet
|
Placebo
n=87 Participants
Placebo tablet
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.43 years
STANDARD_DEVIATION 10.089 • n=5 Participants
|
32.53 years
STANDARD_DEVIATION 8.558 • n=7 Participants
|
32.76 years
STANDARD_DEVIATION 9.327 • n=5 Participants
|
31.25 years
STANDARD_DEVIATION 8.753 • n=4 Participants
|
32.25 years
STANDARD_DEVIATION 9.190 • n=21 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full Analysis Set (FAS): all patients who received at least one dose of the investigational product. (Number of patients at Visit 7 for whom data is available).
The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS\_0-4h. A decrease in the AUCRTSS\_0-4h value represents relief from the HDM allergic symptoms.
Outcome measures
| Measure |
100 IR
n=75 Participants
100 IR house dust mites allergen extract tablet
|
300 IR
n=68 Participants
300 IR house dust mites allergen extract tablet
|
500 IR
n=70 Participants
500 IR house dust mites allergen extract tablet
|
Placebo
n=75 Participants
Placebo tablet
|
|---|---|---|---|---|
|
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge
|
-715.83 RTSS * hour
Standard Error 67.261
|
-769.21 RTSS * hour
Standard Error 70.659
|
-795.58 RTSS * hour
Standard Error 69.877
|
-597.40 RTSS * hour
Standard Error 67.401
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full Analysis Set (FAS): all patients who received at least one dose of the investigational product
Change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the last two hours (2-4h) of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale.
Outcome measures
| Measure |
100 IR
n=75 Participants
100 IR house dust mites allergen extract tablet
|
300 IR
n=68 Participants
300 IR house dust mites allergen extract tablet
|
500 IR
n=70 Participants
500 IR house dust mites allergen extract tablet
|
Placebo
n=75 Participants
Placebo tablet
|
|---|---|---|---|---|
|
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge
|
-390.34 RTSS * hour
Standard Error 40.355
|
-421.39 RTSS * hour
Standard Error 42.400
|
-424.77 RTSS * hour
Standard Error 41.890
|
-299.16 RTSS * hour
Standard Error 40.430
|
Adverse Events
100 IR
Serious events: 1 serious events
Other events: 82 other events
Deaths: 0 deaths
300 IR
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
500 IR
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 IR
n=89 participants at risk
100 IR house dust mites allergen extract tablet
|
300 IR
n=86 participants at risk
300 IR house dust mites allergen extract tablet
|
500 IR
n=93 participants at risk
500 IR house dust mites allergen extract tablet
|
Placebo
n=87 participants at risk
Placebo tablet
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis
|
0.00%
0/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • Number of events 1 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • Number of events 1 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.2%
1/86 • Number of events 1 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
1/89 • Number of events 1 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
Other adverse events
| Measure |
100 IR
n=89 participants at risk
100 IR house dust mites allergen extract tablet
|
300 IR
n=86 participants at risk
300 IR house dust mites allergen extract tablet
|
500 IR
n=93 participants at risk
500 IR house dust mites allergen extract tablet
|
Placebo
n=87 participants at risk
Placebo tablet
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Oral pruritus
|
25.8%
23/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
34.9%
30/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
31.2%
29/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
8.0%
7/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Oedema mouth
|
18.0%
16/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
22.1%
19/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
21.5%
20/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Nausea
|
13.5%
12/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
9.3%
8/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
7.5%
7/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.6%
4/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
6.5%
6/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Lip oedema
|
1.1%
1/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
9.7%
9/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.6%
5/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.2%
1/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
31.5%
28/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
37.2%
32/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
39.8%
37/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
13.8%
12/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
7/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
8.1%
7/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
8.6%
8/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.7%
5/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Ear and labyrinth disorders
Ear pruritus
|
21.3%
19/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
24.4%
21/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
24.7%
23/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
9.2%
8/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Eye disorders
Eye pruritus
|
7.9%
7/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.7%
4/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
6.5%
6/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
6.9%
6/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Nervous system disorders
Headache
|
32.6%
29/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
25.6%
22/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
31.2%
29/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
43.7%
38/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
4/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.8%
5/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.4%
5/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
7/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.7%
4/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.3%
4/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
6/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.2%
3/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Lip pruritus
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.7%
4/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.4%
5/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.8%
5/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.1%
1/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.4%
5/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
5/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
31.5%
28/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
32.6%
28/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
28.0%
26/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
39.1%
34/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Infections and infestations
Pharyngitis
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
9.7%
9/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
General disorders
Chest discomfort
|
7.9%
7/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.7%
4/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.2%
3/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.4%
3/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
General disorders
Fatigue
|
4.5%
4/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.8%
5/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.4%
3/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
General disorders
Pyrexia
|
5.6%
5/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.2%
1/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
0.00%
0/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
4/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.3%
4/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.7%
5/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.2%
2/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.3%
2/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.7%
5/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
2.2%
2/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
6.9%
6/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Investigations
Forced expiratory volume decreased
|
7.9%
7/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
8.1%
7/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.3%
4/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
4.6%
4/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
33.7%
30/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
20.9%
18/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
21.5%
20/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
29.9%
26/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
16/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
12.8%
11/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
7.5%
7/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
13.8%
12/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
6/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.5%
3/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
14.0%
13/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
8.0%
7/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
2/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
7.0%
6/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.4%
5/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
3.4%
3/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
3/89 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.2%
1/86 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
1.1%
1/93 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
5.7%
5/87 • 6 months.
Treatment-emergent adverse events (TEAEs) were defined as any AEs that started on or after the first administration of the investigational product and up to 30 days after the last administration of the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place