Trial Outcomes & Findings for Phase II HDM-SPIRE Safety and Efficacy Study (NCT NCT02150343)
NCT ID: NCT02150343
Last Updated: 2018-06-15
Results Overview
The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3. The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.
COMPLETED
PHASE2
715 participants
Weeks 50 to 52 after randomisation
2018-06-15
Participant Flow
715 participants were randomised on to the study through the IRT. However, one participant was inadvertently randomised before eligibility had been confirmed by the PI, and was withdrawn due to a finding of inspiration/expiration wheeze before receiving any study medication. Therefore results refer to 714 participants throughout.
Participant milestones
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
180
|
178
|
178
|
178
|
|
Overall Study
COMPLETED
|
159
|
158
|
166
|
168
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
12
|
10
|
Reasons for withdrawal
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
2
|
3
|
|
Overall Study
Other
|
2
|
6
|
0
|
2
|
Baseline Characteristics
Phase II HDM-SPIRE Safety and Efficacy Study
Baseline characteristics by cohort
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=180 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=178 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=178 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=178 Participants
8 administrations at 4 weekly intervals
|
Total
n=714 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 12.40 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 11.61 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 12.84 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 12.12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
453 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
261 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
555 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weeks 50 to 52 after randomisationThe primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3. The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Combined Score of Symptoms and Allergy Medication
|
1.69 units on a scale
Standard Error 0.089
|
1.51 units on a scale
Standard Error 0.089
|
1.40 units on a scale
Standard Error 0.086
|
1.56 units on a scale
Standard Error 0.087
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationThe RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (50-52 weeks after randomisation). RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). Questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=158 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=166 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=167 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo
|
2.02 units on a scale
Standard Error 0.098
|
1.76 units on a scale
Standard Error 0.098
|
1.72 units on a scale
Standard Error 0.095
|
1.89 units on a scale
Standard Error 0.095
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationPopulation: The overall number of participants analysed represents the number of subjects that completed the assessment, not all subjects that completed the study (651) completed the Clinical Global Impression of Change (633).
A Global Impression of Change in Rhinoconjunctivitis Symptoms assessment was completed by subjects at the final follow-up visit. Subjects rated their overall allergy symptoms at the end of the study relative to baseline on a seven-point scale as follows:0. very much better; 1. moderately better; 2. a little better; 3. unchanged; 4. a little worse; 5. moderately worse; 6. very much worse. For reporting the individual categories were grouped as follows: moderately or very much better; any improvement; no change and any worsening. Subjects could therefore be reported in more than group and the total number reported does not match the overall number of participants analysed.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=159 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=156 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=158 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=160 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline
Moderately or very much better
|
55 Participants
|
70 Participants
|
61 Participants
|
64 Participants
|
|
Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline
Any improvement
|
101 Participants
|
109 Participants
|
103 Participants
|
109 Participants
|
|
Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline
No Change
|
45 Participants
|
41 Participants
|
48 Participants
|
43 Participants
|
|
Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline
Any worsening
|
13 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationMean Total Rhinoconjunctivitis Symptom Score (TRSS) in HDM-SPIRE treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo
|
8.96 units on a scale
Standard Error 0.468
|
8.03 units on a scale
Standard Error 0.467
|
7.97 units on a scale
Standard Error 0.451
|
8.16 units on a scale
Standard Error 0.455
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationMean daily Total Non-nasal Symptom Score (TNNSS) in HDM-SPIRE treatment groups compared to placebo. TNNSS was the sum of all the non-nasal symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TNNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
|
3.99 units on a scale
Standard Error 0.242
|
3.64 units on a scale
Standard Error 0.242
|
3.53 units on a scale
Standard Error 0.233
|
3.73 units on a scale
Standard Error 0.235
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationTNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
|
4.99 units on a scale
Standard Error 0.244
|
4.40 units on a scale
Standard Error 0.243
|
4.45 units on a scale
Standard Error 0.235
|
4.44 units on a scale
Standard Error 0.237
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationMean RMS (Rescue medication score) in HDM-SPIRE treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 50-52 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo
|
0.57 units on a scale
Standard Error 0.048
|
0.51 units on a scale
Standard Error 0.048
|
0.41 units on a scale
Standard Error 0.047
|
0.55 units on a scale
Standard Error 0.047
|
SECONDARY outcome
Timeframe: Weeks 50 to 52 after randomisationThe number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 50-52 weeks after randomisation.
Outcome measures
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=160 Participants
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=159 Participants
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=165 Participants
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=168 Participants
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo
|
25.9 Days
Standard Error 2.90
|
33.5 Days
Standard Error 2.89
|
33.9 Days
Standard Error 2.80
|
31.1 Days
Standard Error 2.812
|
Adverse Events
HDM-SPIRE 12 Nmol (4 Administrations)
HDM-SPIRE 20 Nmol
HDM-SPIRE 12 Nmol (8 Administrations)
HDM-SPIRE Placebo
Serious adverse events
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=180 participants at risk
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=178 participants at risk
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=178 participants at risk
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=178 participants at risk
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Injury, poisoning and procedural complications
Post procedual haemorrhage
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Cardiac disorders
Angina pectoris
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Psychiatric disorders
Psychotic disorder
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
1/180 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Sinusitis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Cellulitis
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Wound infection
|
0.00%
0/180 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
0.56%
1/178 • Number of events 1 • Upto 52 weeks after randomisation
|
0.00%
0/178 • Upto 52 weeks after randomisation
|
Other adverse events
| Measure |
HDM-SPIRE 12 Nmol (4 Administrations)
n=180 participants at risk
12 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 20 Nmol
n=178 participants at risk
20 nmol given at 4 weekly intervals (4 administrations)
|
HDM-SPIRE 12 Nmol (8 Administrations)
n=178 participants at risk
20 nmol given at 4 weekly intervals (8 administrations)
|
HDM-SPIRE Placebo
n=178 participants at risk
8 administrations at 4 weekly intervals
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
11/180 • Number of events 11 • Upto 52 weeks after randomisation
|
2.2%
4/178 • Number of events 4 • Upto 52 weeks after randomisation
|
4.5%
8/178 • Number of events 9 • Upto 52 weeks after randomisation
|
5.1%
9/178 • Number of events 11 • Upto 52 weeks after randomisation
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
6/180 • Number of events 7 • Upto 52 weeks after randomisation
|
1.1%
2/178 • Number of events 2 • Upto 52 weeks after randomisation
|
7.9%
14/178 • Number of events 14 • Upto 52 weeks after randomisation
|
3.4%
6/178 • Number of events 9 • Upto 52 weeks after randomisation
|
|
Nervous system disorders
Headache
|
5.6%
10/180 • Number of events 26 • Upto 52 weeks after randomisation
|
6.2%
11/178 • Number of events 30 • Upto 52 weeks after randomisation
|
7.3%
13/178 • Number of events 28 • Upto 52 weeks after randomisation
|
6.7%
12/178 • Number of events 16 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Nasopharyngitis
|
20.6%
37/180 • Number of events 59 • Upto 52 weeks after randomisation
|
18.0%
32/178 • Number of events 54 • Upto 52 weeks after randomisation
|
21.3%
38/178 • Number of events 54 • Upto 52 weeks after randomisation
|
23.0%
41/178 • Number of events 58 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
22/180 • Number of events 27 • Upto 52 weeks after randomisation
|
13.5%
24/178 • Number of events 32 • Upto 52 weeks after randomisation
|
11.8%
21/178 • Number of events 32 • Upto 52 weeks after randomisation
|
11.2%
20/178 • Number of events 26 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Sinusitis
|
7.2%
13/180 • Number of events 16 • Upto 52 weeks after randomisation
|
7.9%
14/178 • Number of events 15 • Upto 52 weeks after randomisation
|
8.4%
15/178 • Number of events 15 • Upto 52 weeks after randomisation
|
6.7%
12/178 • Number of events 16 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Influenza
|
3.9%
7/180 • Number of events 7 • Upto 52 weeks after randomisation
|
6.7%
12/178 • Number of events 15 • Upto 52 weeks after randomisation
|
8.4%
15/178 • Number of events 15 • Upto 52 weeks after randomisation
|
6.2%
11/178 • Number of events 12 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Urinary tract infection
|
2.8%
5/180 • Number of events 6 • Upto 52 weeks after randomisation
|
3.9%
7/178 • Number of events 7 • Upto 52 weeks after randomisation
|
5.6%
10/178 • Number of events 14 • Upto 52 weeks after randomisation
|
3.4%
6/178 • Number of events 9 • Upto 52 weeks after randomisation
|
|
Infections and infestations
Bronchitis
|
5.0%
9/180 • Number of events 9 • Upto 52 weeks after randomisation
|
2.2%
4/178 • Number of events 4 • Upto 52 weeks after randomisation
|
3.4%
6/178 • Number of events 8 • Upto 52 weeks after randomisation
|
3.9%
7/178 • Number of events 7 • Upto 52 weeks after randomisation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Wording included in the clinical protocol - The Investigator and Circassia will normally prepare a manuscript together. To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.
- Publication restrictions are in place
Restriction type: OTHER