Trial Outcomes & Findings for The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen (NCT NCT00999466)
NCT ID: NCT00999466
Last Updated: 2016-02-26
Results Overview
Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
COMPLETED
PHASE2
60 participants
Pre-treatment (Baseline measurement)
2016-02-26
Participant Flow
Participant milestones
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Pilot Part
STARTED
|
6
|
0
|
3
|
|
Pilot Part
COMPLETED
|
6
|
0
|
3
|
|
Pilot Part
NOT COMPLETED
|
0
|
0
|
0
|
|
Main Part
STARTED
|
0
|
26
|
25
|
|
Main Part
COMPLETED
|
0
|
22
|
21
|
|
Main Part
NOT COMPLETED
|
0
|
4
|
4
|
Reasons for withdrawal
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Main Part
Withdrawal by Subject
|
0
|
0
|
2
|
|
Main Part
Adverse Event
|
0
|
4
|
2
|
Baseline Characteristics
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
Baseline characteristics by cohort
| Measure |
AZD8848, 30 μg
n=6 Participants
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=26 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=28 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.3 Years
n=5 Participants
|
33.0 Years
n=7 Participants
|
32.3 Years
n=5 Participants
|
33.9 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment (Baseline measurement)Population: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Late Asthmatic Response (LAR) - Pre-treatment
|
—
|
0.814 ratio
Standard Deviation 0.450
|
1.01 ratio
Standard Deviation 0.784
|
PRIMARY outcome
Timeframe: 1 week after last dosePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose
|
—
|
0.616 ratio
Standard Deviation 0.296
|
0.970 ratio
Standard Deviation 0.641
|
PRIMARY outcome
Timeframe: 4 weeks after last dosePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=21 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose
|
—
|
0.759 ratio
Standard Deviation 0.397
|
0.722 ratio
Standard Deviation 0.584
|
SECONDARY outcome
Timeframe: Pre-treatment (Baseline measurement)Population: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Early Asthmatic Response (EAR) - Pre-treatment
|
—
|
0.524 ratio
Standard Deviation 0.241
|
0.611 ratio
Standard Deviation 0.362
|
SECONDARY outcome
Timeframe: 1 week after last dosePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose
|
—
|
0.468 ratio
Standard Deviation 0.361
|
0.624 ratio
Standard Deviation 0.362
|
SECONDARY outcome
Timeframe: 4 weeks after last dosePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=21 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose
|
—
|
0.510 ratio
Standard Deviation 0.240
|
0.591 ratio
Standard Deviation 0.401
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge
|
—
|
0.564 mg/mL
Interval 0.004 to 11.1
|
0.609 mg/mL
Interval 0.063 to 5.69
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=23 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge
|
—
|
0.425 mg/mL
Interval 0.123 to 6.25
|
0.364 mg/mL
Interval 0.063 to 10.2
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=21 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.488 mg/mL
Interval 0.063 to 3.01
|
0.454 mg/mL
Interval 0.063 to 8.25
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=21 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=21 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
0.691 mg/mL
Interval 0.063 to 9.13
|
0.340 mg/mL
Interval 0.063 to 17.8
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=22 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=21 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.468 mg/mL
Interval 0.063 to 2.47
|
0.504 mg/mL
Interval 0.072 to 4.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=21 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=20 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
0.326 mg/mL
Interval 0.082 to 4.08
|
0.508 mg/mL
Interval 0.063 to 29.1
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge
|
—
|
8.9 pg/mL
Interval 3.5 to 25.0
|
4.8 pg/mL
Interval 0.9 to 24.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge
|
—
|
13 pg/mL
Interval 2.8 to 156.0
|
12 pg/mL
Interval 5.3 to 38.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
6.5 pg/mL
Interval 1.7 to 46.0
|
5.3 pg/mL
Interval 0.9 to 23.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
11 pg/mL
Interval 2.4 to 539.0
|
8.4 pg/mL
Interval 1.1 to 41.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
5.1 pg/mL
Interval 0.9 to 113.0
|
9.4 pg/mL
Interval 1.5 to 510.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
13 pg/mL
Interval 4.3 to 125.0
|
7.9 pg/mL
Interval 4.4 to 23.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge
|
—
|
37 pg/mL
Interval 6.5 to 127.0
|
23 pg/mL
Interval 0.8 to 243.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge
|
—
|
41 pg/mL
Interval 13.0 to 322.0
|
44 pg/mL
Interval 13.0 to 320.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
37 pg/mL
Interval 7.8 to 614.0
|
36 pg/mL
Interval 4.5 to 139.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
45 pg/mL
Interval 7.0 to 293.0
|
37 pg/mL
Interval 13.0 to 217.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
29 pg/mL
Interval 6.6 to 303.0
|
43 pg/mL
Interval 7.6 to 366.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
72 pg/mL
Interval 15.0 to 198.0
|
41 pg/mL
Interval 15.0 to 224.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge
|
—
|
0.83 pg/mL
Interval 0.4 to 9.0
|
0.87 pg/mL
Interval 0.4 to 5.6
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge
|
—
|
7.1 pg/mL
Interval 0.4 to 74.0
|
5.8 pg/mL
Interval 0.4 to 27.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.82 pg/mL
Interval 0.4 to 4.5
|
1.3 pg/mL
Interval 0.4 to 11.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
7.8 pg/mL
Interval 1.1 to 38.0
|
5.4 pg/mL
Interval 0.9 to 35.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
1.2 pg/mL
Interval 0.4 to 5.5
|
1.7 pg/mL
Interval 0.4 to 24.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
5.7 pg/mL
Interval 0.8 to 38.0
|
8.0 pg/mL
Interval 2.1 to 47.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge
|
—
|
15 pg/mL
Interval 4.4 to 61.0
|
9.4 pg/mL
Interval 0.4 to 189.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge
|
—
|
28 pg/mL
Interval 5.7 to 252.0
|
27 pg/mL
Interval 1.7 to 75.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
15 pg/mL
Interval 2.4 to 43.0
|
9.6 pg/mL
Interval 0.4 to 37.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
26 pg/mL
Interval 5.2 to 142.0
|
23 pg/mL
Interval 3.1 to 76.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
12 pg/mL
Interval 0.6 to 123.0
|
21 pg/mL
Interval 6.3 to 1317.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
20 pg/mL
Interval 5.3 to 174.0
|
29 pg/mL
Interval 10.0 to 107.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge
|
—
|
766 pg/mL
Interval 138.0 to 1784.0
|
522 pg/mL
Interval 8.5 to 2500.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge
|
—
|
1300 pg/mL
Interval 422.0 to 2500.0
|
1450 pg/mL
Interval 549.0 to 2500.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
720 pg/mL
Interval 186.0 to 2500.0
|
609 pg/mL
Interval 63.0 to 2366.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
1272 pg/mL
Interval 284.0 to 2500.0
|
1270 pg/mL
Interval 240.0 to 2500.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
496 pg/mL
Interval 68.0 to 2500.0
|
1012 pg/mL
Interval 176.0 to 2500.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
1500 pg/mL
Interval 783.0 to 2500.0
|
1304 pg/mL
Interval 595.0 to 2500.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge
|
—
|
0.57 pg/mL
Interval 0.5 to 1.1
|
0.63 pg/mL
Interval 0.5 to 2.6
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge
|
—
|
0.86 pg/mL
Interval 0.5 to 32.0
|
0.68 pg/mL
Interval 0.5 to 1.7
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.60 pg/mL
Interval 0.5 to 2.5
|
0.75 pg/mL
Interval 0.5 to 34.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
0.79 pg/mL
Interval 0.5 to 53.0
|
0.82 pg/mL
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.54 pg/mL
Interval 0.5 to 0.9
|
0.95 pg/mL
Interval 0.5 to 17.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
0.68 pg/mL
Interval 0.5 to 1.9
|
0.67 pg/mL
Interval 0.5 to 5.7
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge
|
—
|
1.3 pg/mL
Interval 1.2 to 3.6
|
1.4 pg/mL
Interval 1.2 to 3.8
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge
|
—
|
3.0 pg/mL
Interval 1.2 to 25.0
|
3.1 pg/mL
Interval 1.2 to 9.2
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
1.3 pg/mL
Interval 1.2 to 1.9
|
1.8 pg/mL
Interval 1.2 to 8.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
3.0 pg/mL
Interval 1.2 to 8.3
|
2.8 pg/mL
Interval 1.2 to 20.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
1.3 pg/mL
Interval 1.2 to 2.1
|
1.6 pg/mL
Interval 1.2 to 6.5
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
2.5 pg/mL
Interval 1.2 to 11.0
|
3.1 pg/mL
Interval 1.2 to 17.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge
|
—
|
2.7 Cell count/g
Interval 1.3 to 6.8
|
2.7 Cell count/g
Interval 0.67 to 14.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge
|
—
|
5.0 Cell count/g
Interval 1.1 to 35.0
|
3.5 Cell count/g
Interval 0.25 to 7.9
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
3.7 Cell count/g
Interval 0.84 to 16.0
|
3.0 Cell count/g
Interval 0.95 to 20.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
5.0 Cell count/g
Interval 1.9 to 19.0
|
4.2 Cell count/g
Interval 0.55 to 18.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
1.9 Cell count/g
Interval 0.29 to 9.4
|
2.6 Cell count/g
Interval 0.58 to 12.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
5.2 Cell count/g
Interval 2.2 to 15.0
|
4.0 Cell count/g
Interval 1.2 to 12.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge
|
—
|
0.13 10^6 cells/g
Interval 0.015 to 0.46
|
0.12 10^6 cells/g
Interval 0.008 to 3.7
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge
|
—
|
0.64 10^6 cells/g
Interval 0.008 to 6.5
|
0.81 10^6 cells/g
Interval 0.023 to 3.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.18 10^6 cells/g
Interval 0.033 to 2.1
|
0.23 10^6 cells/g
Interval 0.008 to 2.8
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
0.94 10^6 cells/g
Interval 0.12 to 3.8
|
0.82 10^6 cells/g
Interval 0.066 to 6.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.13 10^6 cells/g
Interval 0.009 to 2.2
|
0.21 10^6 cells/g
Interval 0.032 to 1.1
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
1.0 10^6 cells/g
Interval 0.2 to 5.8
|
0.96 10^6 cells/g
Interval 0.13 to 4.6
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge
|
—
|
0.75 10^6 cells/g
Interval 0.026 to 4.2
|
0.93 10^6 cells/g
Interval 0.026 to 10.0
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge
|
—
|
1.9 10^6 cells/g
Interval 0.45 to 25.0
|
1.5 10^6 cells/g
Interval 0.061 to 4.1
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
1.5 10^6 cells/g
Interval 0.065 to 15.0
|
0.91 10^6 cells/g
Interval 0.026 to 17.0
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
2.1 10^6 cells/g
Interval 0.36 to 9.1
|
1.7 10^6 cells/g
Interval 0.22 to 15.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.80 10^6 cells/g
Interval 0.097 to 7.5
|
1.3 10^6 cells/g
Interval 0.072 to 9.3
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
2.6 10^6 cells/g
Interval 0.81 to 11.0
|
1.6 10^6 cells/g
Interval 0.4 to 7.8
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge
|
—
|
1.1 10^6 cells/g
Interval 0.29 to 2.2
|
0.59 10^6 cells/g
Interval 0.004 to 3.7
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge
|
—
|
1.1 10^6 cells/g
Interval 0.13 to 4.9
|
0.60 10^6 cells/g
Interval 0.1 to 2.1
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.80 10^6 cells/g
Interval 0.088 to 3.1
|
0.36 10^6 cells/g
Interval 0.004 to 2.4
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
1.0 10^6 cells/g
Interval 0.2 to 5.2
|
0.77 10^6 cells/g
Interval 0.12 to 3.0
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.47 10^6 cells/g
Interval 0.004 to 1.9
|
0.58 10^6 cells/g
Interval 0.22 to 1.6
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
0.56 10^6 cells/g
Interval 0.087 to 1.8
|
0.74 10^6 cells/g
Interval 0.083 to 4.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge
|
—
|
0.004 10^6 cells/g
Interval 0.002 to 0.027
|
0.004 10^6 cells/g
Interval 0.002 to 0.059
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge
|
—
|
0.008 10^6 cells/g
Interval 0.002 to 0.086
|
0.004 10^6 cells/g
Interval 0.002 to 0.06
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.002 10^6 cells/g
Interval 0.002 to 0.016
|
0.003 10^6 cells/g
Interval 0.002 to 0.046
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
0.003 10^6 cells/g
Interval 0.002 to 0.04
|
0.003 10^6 cells/g
Interval 0.002 to 0.045
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.005 10^6 cells/g
Interval 0.002 to 0.035
|
0.005 10^6 cells/g
Interval 0.002 to 0.036
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
0.005 10^6 cells/g
Interval 0.002 to 0.049
|
0.003 10^6 cells/g
Interval 0.002 to 0.012
|
SECONDARY outcome
Timeframe: Pre-treatment, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=12 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge
|
—
|
0.045 10^6 cells/g
Interval 0.001 to 0.29
|
0.053 10^6 cells/g
Interval 0.001 to 0.59
|
SECONDARY outcome
Timeframe: Pre-treatment, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge
|
—
|
0.078 10^6 cells/g
Interval 0.001 to 3.5
|
0.073 10^6 cells/g
Interval 0.001 to 0.35
|
SECONDARY outcome
Timeframe: 1 week after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=19 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge
|
—
|
0.11 10^6 cells/g
Interval 0.008 to 0.39
|
0.045 10^6 cells/g
Interval 0.001 to 1.4
|
SECONDARY outcome
Timeframe: 1 week after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=17 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=17 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge
|
—
|
0.067 10^6 cells/g
Interval 0.001 to 0.56
|
0.071 10^6 cells/g
Interval 0.001 to 0.47
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, pre allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=16 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge
|
—
|
0.045 10^6 cells/g
Interval 0.005 to 0.2
|
0.054 10^6 cells/g
Interval 0.001 to 0.43
|
SECONDARY outcome
Timeframe: 4 weeks after last dose, post allergen challengePopulation: There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Outcome measures
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
n=13 Participants
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
n=16 Participants
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge
|
—
|
0.037 10^6 cells/g
Interval 0.001 to 0.17
|
0.082 10^6 cells/g
Interval 0.018 to 0.24
|
Adverse Events
AZD8848, 30 μg
AZD8848, 60 μg
Placebo
Serious adverse events
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Infections and infestations
Tonsillitis Bacterial
|
0.00%
0/6
|
0.00%
0/26
|
3.6%
1/28
|
Other adverse events
| Measure |
AZD8848, 30 μg
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
|
AZD8848, 60 μg
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
|
Placebo
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
|
|---|---|---|---|
|
Ear and labyrinth disorders
TINNITUS
|
16.7%
1/6
|
0.00%
0/26
|
3.6%
1/28
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/6
|
0.00%
0/26
|
7.1%
2/28
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/6
|
0.00%
0/26
|
7.1%
2/28
|
|
Eye disorders
EYE SWELLING
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
General disorders
Pain
|
0.00%
0/6
|
3.8%
1/26
|
7.1%
2/28
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/6
|
7.7%
2/26
|
7.1%
2/28
|
|
General disorders
PYREXIA
|
33.3%
2/6
|
15.4%
4/26
|
7.1%
2/28
|
|
Immune system disorders
ALLERGY TO ARTHROPOD BITE
|
0.00%
0/6
|
7.7%
2/26
|
0.00%
0/28
|
|
Infections and infestations
NASAL VESTIBULITIS
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6
|
7.7%
2/26
|
17.9%
5/28
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
1/6
|
7.7%
2/26
|
14.3%
4/28
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6
|
3.8%
1/26
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
1/6
|
11.5%
3/26
|
3.6%
1/28
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Nervous system disorders
LETHARGY
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Nervous system disorders
DIZZINESS
|
16.7%
1/6
|
3.8%
1/26
|
0.00%
0/28
|
|
Nervous system disorders
HEADACHE
|
66.7%
4/6
|
57.7%
15/26
|
42.9%
12/28
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISCOLOURED
|
0.00%
0/6
|
0.00%
0/26
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
16.7%
1/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL MUCOSAL DISORDER
|
50.0%
3/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM ULCERATION
|
33.3%
2/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
UPPER AIRWAY OBSTRUCTION
|
66.7%
4/6
|
0.00%
0/26
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
50.0%
3/6
|
3.8%
1/26
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
16.7%
1/6
|
3.8%
1/26
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
16.7%
1/6
|
3.8%
1/26
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
1/6
|
7.7%
2/26
|
25.0%
7/28
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
66.7%
4/6
|
7.7%
2/26
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/6
|
7.7%
2/26
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
33.3%
2/6
|
7.7%
2/26
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
66.7%
4/6
|
11.5%
3/26
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/6
|
11.5%
3/26
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/6
|
15.4%
4/26
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
33.3%
2/6
|
19.2%
5/26
|
28.6%
8/28
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
33.3%
2/6
|
0.00%
0/26
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
RASH
|
16.7%
1/6
|
7.7%
2/26
|
7.1%
2/28
|
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