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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Pre-treatment (Baseline measurement)

Results posted on

2016-02-26

Participant Flow

Participant milestones

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

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

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

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 dose

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, 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

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 dose

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, 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

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

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 dose

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 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Outcome measures

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 dose

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 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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 challenge

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

AZD8848, 60 μg

Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths

Placebo

Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths

Serious adverse events

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

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

Gerard Lynch

AstraZeneca

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