Trial Outcomes & Findings for Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848 (NCT NCT01185080)
NCT ID: NCT01185080
Last Updated: 2016-01-07
Results Overview
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
COMPLETED
PHASE2
93 participants
During 1st day to 7th day of Allergen challenge period.
2016-01-07
Participant Flow
There were 93 patients enrolled in the study, who 83 of them were randomized. Of the 10 patients who were not randomized, 3 patients due to "patient decision" and 7 patients due to "Eligibility criteria not fulfilled" were not randomized.
Participant milestones
| Measure |
AZD8848 20 μg x3
20 μg AZD8848 three times weekly
|
Placebo
Placebo three times weekly
|
AZD8848 60 μg
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
16
|
17
|
|
Overall Study
COMPLETED
|
49
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
AZD8848 20 μg x3
20 μg AZD8848 three times weekly
|
Placebo
Placebo three times weekly
|
AZD8848 60 μg
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Personal reasons
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Baseline characteristics by cohort
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=16 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=17 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.7 years
n=5 Participants
|
28.8 years
n=7 Participants
|
31.0 years
n=5 Participants
|
29.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During 1st day to 7th day of Allergen challenge period.Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
|
4.52 Scores on a scale
Interval 1.43 to 7.71
|
4.97 Scores on a scale
Interval 2.86 to 6.43
|
4.69 Scores on a scale
Interval 3.14 to 7.0
|
PRIMARY outcome
Timeframe: During 4th day to 7th day of Allergen challenge period.Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=49 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
|
4.45 Scores on a scale
Interval 1.25 to 8.25
|
5.36 Scores on a scale
Interval 3.25 to 8.0
|
4.42 Scores on a scale
Interval 2.75 to 7.5
|
PRIMARY outcome
Timeframe: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=14 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
|
1.81 Scores on a scale
Interval 0.286 to 4.14
|
2.14 Scores on a scale
Interval 0.286 to 3.57
|
1.48 Scores on a scale
Interval 0.143 to 3.29
|
PRIMARY outcome
Timeframe: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=14 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
|
2.06 Scores on a scale
Interval 0.143 to 4.71
|
2.32 Scores on a scale
Interval 0.0 to 4.57
|
1.96 Scores on a scale
Interval 0.143 to 4.43
|
PRIMARY outcome
Timeframe: During 1st day to 7th day of Allergen challenge period.Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
|
117 L/min
Interval 37.9 to 197.0
|
127 L/min
Interval 67.0 to 214.0
|
129 L/min
Interval 50.0 to 243.0
|
PRIMARY outcome
Timeframe: During 4th day to 7th day of Allergen challenge period.Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=49 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
|
121 L/min
Interval 37.5 to 200.0
|
128 L/min
Interval 77.5 to 220.0
|
135 L/min
Interval 52.5 to 245.0
|
PRIMARY outcome
Timeframe: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=14 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
|
136 L/min
Interval 51.4 to 237.0
|
148 L/min
Interval 84.3 to 237.0
|
148 L/min
Interval 71.4 to 234.0
|
PRIMARY outcome
Timeframe: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=14 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
|
145 L/min
Interval 52.9 to 222.0
|
149 L/min
Interval 71.4 to 253.0
|
147 L/min
Interval 68.6 to 251.0
|
SECONDARY outcome
Timeframe: Pre-dose on visit 2 (baseline)Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=16 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=17 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
|
0.38 Scores on a scale
Standard Deviation 0.697
|
0.75 Scores on a scale
Standard Deviation 1.291
|
0.35 Scores on a scale
Standard Deviation 0.493
|
SECONDARY outcome
Timeframe: Pre-dose on visit 11 (end of 3rd week of treatment)Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=49 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=15 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
|
1.20 Scores on a scale
Standard Deviation 1.020
|
0.67 Scores on a scale
Standard Deviation 1.047
|
0.80 Scores on a scale
Standard Deviation 0.862
|
SECONDARY outcome
Timeframe: Pre-dose on visit 2 (baseline)Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=50 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=16 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=17 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
|
170.4 L/min
Standard Deviation 54.593
|
176.9 L/min
Standard Deviation 63.005
|
169.4 L/min
Standard Deviation 62.497
|
SECONDARY outcome
Timeframe: Pre-dose on visit 11 (end of 3rd week of treatment)Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=49 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=15 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
|
168.1 L/min
Standard Deviation 52.070
|
191.3 L/min
Standard Deviation 48.824
|
182.7 L/min
Standard Deviation 61.350
|
SECONDARY outcome
Timeframe: Baseline to 1st day of visit 15Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=46 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=15 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=16 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma
|
2.89 ratio
Interval 2.45 to 3.4
|
0.803 ratio
Interval 0.6 to 1.07
|
3.90 ratio
Interval 2.96 to 5.15
|
SECONDARY outcome
Timeframe: Baseline to 1st day of visit 15Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15.
Outcome measures
| Measure |
AZD8848 20 μg x3
n=48 Participants
20 μg AZD8848 three times weekly
|
Placebo
n=14 Participants
Placebo three times weekly
|
AZD8848 60 μg
n=15 Participants
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage
|
30.0 ratio
Interval 21.99 to 40.81
|
1.66 ratio
Interval 0.93 to 2.97
|
26.9 ratio
Interval 15.52 to 46.56
|
Adverse Events
AZD8848 20 μg x3
Placebo
AZD8848 60 μg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD8848 20 μg x3
n=50 participants at risk
20 μg AZD8848 three times weekly
|
Placebo
n=16 participants at risk
Placebo three times weekly
|
AZD8848 60 μg
n=17 participants at risk
60 μg AZD8848 once weekly and placebo twice weekly
|
|---|---|---|---|
|
Eye disorders
Eye Pruritus
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
1/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/50
|
6.2%
1/16
|
5.9%
1/17
|
|
General disorders
Asthenia
|
8.0%
4/50
|
0.00%
0/16
|
5.9%
1/17
|
|
General disorders
Chills
|
12.0%
6/50
|
0.00%
0/16
|
17.6%
3/17
|
|
General disorders
Fatigue
|
14.0%
7/50
|
6.2%
1/16
|
5.9%
1/17
|
|
General disorders
Feeling abnormal
|
6.0%
3/50
|
0.00%
0/16
|
5.9%
1/17
|
|
General disorders
Irritability
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
General disorders
Pain
|
6.0%
3/50
|
6.2%
1/16
|
17.6%
3/17
|
|
General disorders
Pyrexia
|
22.0%
11/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
5/50
|
12.5%
2/16
|
0.00%
0/17
|
|
Infections and infestations
Sinusitus
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Face injury
|
2.0%
1/50
|
0.00%
0/16
|
11.8%
2/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50
|
0.00%
0/16
|
0.00%
0/17
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Nervous system disorders
Disgeusia
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
40.0%
20/50
|
31.2%
5/16
|
17.6%
3/17
|
|
Nervous system disorders
Migraine
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Psychiatric disorders
Stress
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
48.0%
24/50
|
6.2%
1/16
|
35.3%
6/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
24.0%
12/50
|
6.2%
1/16
|
23.5%
4/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.0%
1/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
34.0%
17/50
|
18.8%
3/16
|
35.3%
6/17
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
14.0%
7/50
|
0.00%
0/16
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/50
|
0.00%
0/16
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
8.0%
4/50
|
0.00%
0/16
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
14.0%
7/50
|
0.00%
0/16
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
28.0%
14/50
|
18.8%
3/16
|
23.5%
4/17
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
10/50
|
25.0%
4/16
|
52.9%
9/17
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50
|
6.2%
1/16
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Scab
|
8.0%
4/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Vascular disorders
Hypertension
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50
|
0.00%
0/16
|
5.9%
1/17
|
|
Infections and infestations
Herpes Virus Infection
|
6.0%
3/50
|
0.00%
0/16
|
0.00%
0/17
|
|
Eye disorders
Eczema Eyelids
|
0.00%
0/50
|
6.2%
1/16
|
0.00%
0/17
|
|
Eye disorders
Eye Oedema
|
0.00%
0/50
|
0.00%
0/16
|
5.9%
1/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between PI and Sponsor (AZ) or its agents that restricts the PI's right to discuss/publish trial results after the trial is completed. The PI agrees to collaborate in good faith with AZ with regards to content and formation of any publication or disclosure to be made by PI and to pay due consideration to opinions offered by AZ
- Publication restrictions are in place
Restriction type: OTHER