Trial Outcomes & Findings for The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen (NCT NCT01225549)
NCT ID: NCT01225549
Last Updated: 2015-04-02
Results Overview
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
From Randomization to end of treatment
Results posted on
2015-04-02
Participant Flow
Patients were enrolled from 4 centres in the AllerGen CIC group in Canada.
Total 27 patients enrolled, 20 (74.1%) patients were randomised to receive a treatment sequence consisting of 4 different treatment in random order. From 20 randomised patients, 18 (90%) patients completed the study and 2 (10%) patients were withdrawn from the study due to consumption of disallowed medication
Participant milestones
| Measure |
ACBP
AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
|
APBC
AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
|
BACP
AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
|
BPCA
AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
|
CAPB
Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
|
CBAP
Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
|
CBPA
Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
|
PBAC
Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
|
PCAB
Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
|
PCBA
Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 - First Treatment Period
STARTED
|
1
|
4
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 1 - First Treatment Period
COMPLETED
|
1
|
4
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 1 - First Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Washout
STARTED
|
1
|
4
|
3
|
1
|
1
|
1
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3
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1
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4
|
1
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Period 2 - Washout
COMPLETED
|
1
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4
|
3
|
1
|
1
|
1
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3
|
1
|
4
|
1
|
|
Period 2 - Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 - Second Treatment Period
STARTED
|
1
|
4
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 3 - Second Treatment Period
COMPLETED
|
1
|
4
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 3 - Second Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 - Washout
STARTED
|
1
|
4
|
3
|
1
|
1
|
1
|
3
|
1
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4
|
1
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Period 4 - Washout
COMPLETED
|
1
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3
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3
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1
|
1
|
1
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3
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1
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4
|
1
|
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Period 4 - Washout
NOT COMPLETED
|
0
|
1
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0
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0
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0
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0
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0
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0
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0
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0
|
|
Period 5 - Third Treatment Period
STARTED
|
1
|
3
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 5 - Third Treatment Period
COMPLETED
|
1
|
3
|
3
|
1
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 5 - Third Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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|
Period 6 - Washout
STARTED
|
1
|
3
|
3
|
1
|
1
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1
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3
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1
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4
|
1
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Period 6 - Washout
COMPLETED
|
1
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3
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3
|
0
|
1
|
1
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3
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1
|
4
|
1
|
|
Period 6 - Washout
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
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0
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0
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0
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0
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0
|
|
Period 7 - Fourth Treatment Period
STARTED
|
1
|
3
|
3
|
0
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 7 - Fourth Treatment Period
COMPLETED
|
1
|
3
|
3
|
0
|
1
|
1
|
3
|
1
|
4
|
1
|
|
Period 7 - Fourth Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ACBP
AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
|
APBC
AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
|
BACP
AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
|
BPCA
AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
|
CAPB
Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
|
CBAP
Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
|
CBPA
Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
|
PBAC
Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
|
PCAB
Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
|
PCBA
Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 4 - Washout
Disallowed medication
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 6 - Washout
Disallowed medication
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
Baseline characteristics by cohort
| Measure |
Baseline Total
n=20 Participants
Total number of patients randomised and treated in the study
|
|---|---|
|
Age, Continuous
|
29.6 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Randomization to end of treatmentPopulation: PD Analysis set
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=19 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=19 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
|
90.97 Percentage
Interval 73.2 to 100.0
|
91.32 Percentage
Interval 76.8 to 101.6
|
87.28 Percentage
Interval 56.6 to 103.2
|
85.83 Percentage
Interval 69.6 to 102.8
|
SECONDARY outcome
Timeframe: From Randomization to end of treatmentPopulation: PD Analysis set
Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=19 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=19 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
|
69.75 Percentage
Interval 41.0 to 94.0
|
69.57 Percentage
Interval 41.8 to 92.6
|
67.98 Percentage
Interval 41.6 to 92.4
|
69.30 Percentage
Interval 35.2 to 92.6
|
SECONDARY outcome
Timeframe: From Randomization to end of treatmentPopulation: PD Analysis set
AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=19 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=19 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
AUC over 0-3 (Average EAR)
|
83.82 Percentage
Interval 64.1 to 95.25
|
83.71 Percentage
Interval 65.7 to 96.68
|
81.90 Percentage
Interval 56.5 to 93.9
|
82.26 Percentage
Interval 57.1 to 97.97
|
|
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
AUC over 3-7 (Average LAR)
|
96.30 Percentage
Interval 87.62 to 104.67
|
96.53 Percentage
Interval 85.7 to 103.93
|
93.39 Percentage
Interval 69.69 to 107.34
|
92.50 Percentage
Interval 80.77 to 106.23
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose)Population: PD Analysis set
The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=19 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=20 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Airway Hyperresponsiveness by Assessment of Methacholine PC20
|
1.560 mg/mL
Interval 0.11 to 32.0
|
1.651 mg/mL
Interval 0.14 to 36.8
|
1.688 mg/mL
Interval 0.08 to 17.75
|
1.538 mg/mL
Interval 0.07 to 53.7
|
SECONDARY outcome
Timeframe: Day 5 ([post-dose] pre allergen challenge)The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=19 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=20 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Airway Hyperresponsiveness by Assessment of Methacholine PC20
|
1.755 mg/mL
Interval 0.13 to 32.0
|
2.693 mg/mL
Interval 0.26 to 64.0
|
2.477 mg/mL
Interval 0.19 to 18.7
|
2.034 mg/mL
Interval 0.09 to 53.8
|
SECONDARY outcome
Timeframe: Day 7 ([post-dose] 24 hours post allergen challenge)The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=17 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=18 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Airway Hyperresponsiveness by Assessment of Methacholine PC20
|
2.017 mg/mL
Interval 0.21 to 32.0
|
2.007 mg/mL
Interval 0.15 to 45.89
|
1.666 mg/mL
Interval 0.06 to 17.19
|
1.214 mg/mL
Interval 0.06 to 35.1
|
SECONDARY outcome
Timeframe: Day 5 (post dose)Population: PD Analysis set
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=16 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=15 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=15 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=16 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Changes in Sputum Eosinophils Differentials (Percentage)
|
1.891 Percentage
Standard Deviation 8.375
|
-3.2 Percentage
Standard Deviation 9.162
|
-1.825 Percentage
Standard Deviation 4.342
|
-0.016 Percentage
Standard Deviation 1.835
|
SECONDARY outcome
Timeframe: Day 6 ([post dose] 7 hours post allergen challenge)The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=15 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=15 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=14 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=15 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Changes in Sputum Eosinophils Differentials (Percentage)
|
0.633 Percentage
Standard Deviation 6.011
|
0.592 Percentage
Standard Deviation 9.658
|
7.500 Percentage
Standard Deviation 11.800
|
12.333 Percentage
Standard Deviation 14.260
|
SECONDARY outcome
Timeframe: Day 7 ([post dose] 24 hours post allergen challenge)The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Outcome measures
| Measure |
Arm 1 - 75ug AZD5423
n=16 Participants
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=14 Participants
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=15 Participants
200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=14 Participants
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Changes in Sputum Eosinophils Differentials (Percentage)
|
0.688 Percentage
Standard Deviation 8.230
|
2.286 Percentage
Standard Deviation 15.417
|
6.967 Percentage
Standard Deviation 11.697
|
5.634 Percentage
Standard Deviation 5.520
|
Adverse Events
Arm 1 - 75ug AZD5423
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2 - 300ug AZD5423
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3 - 2x200ug Budesonide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 4 - Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - 75ug AZD5423
n=19 participants at risk
75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 2 - 300ug AZD5423
n=19 participants at risk
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 3 - 2x200ug Budesonide
n=19 participants at risk
2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
|
Arm 4 - Placebo
n=20 participants at risk
Placebo administered in any of the first, second, third or fourth period of a particular sequence.
|
|---|---|---|---|---|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.3%
1/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
DYSPHAGIA
|
5.3%
1/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/20
|
|
General disorders
PYREXIA
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/19
|
0.00%
0/19
|
10.5%
2/19
|
0.00%
0/20
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
PHARYNGITIS BACTERIAL
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
SCRATCH
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/20
|
|
Investigations
HELICOBACTER TEST POSITIVE
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Nervous system disorders
HEADACHE
|
10.5%
2/19
|
0.00%
0/19
|
5.3%
1/19
|
5.0%
1/20
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/19
|
0.00%
0/19
|
5.3%
1/19
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.5%
2/19
|
0.00%
0/19
|
5.3%
1/19
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/19
|
5.3%
1/19
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/19
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall not publish any results until (i) the date of the first Study results publication, or in case of a Multi-Centre Study the first Multi-Centre Results publication, agreed by the participating sites, and (ii) the end of the eighteen (18) month period following the completion or early termination of the Study at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER