Allergic Asthma
Conditions
Brief summary
AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.
Interventions
DRUGAZD8848
Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
DRUGPlacebo
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* FEV1 \> 70 % of predicted normal pre-bronchodilator * Documented history of asthma * Presence of allergic sensitivity
Exclusion criteria
* Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. * Symptomatic allergic rhinitis * Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1, Late Asthmatic Response (LAR) - Pre-treatment | Pre-treatment (Baseline measurement) | 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. |
| FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose | 1 week after last dose | 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. |
| FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose | 4 weeks after last dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose | 1 week after last dose | 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. |
| FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose | 4 weeks after last dose | 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. |
| PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 |
| Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge | Pre-treatment, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge | Pre-treatment, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge | 4 weeks after last dose, pre allergen challenge | — |
| Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge | 4 weeks after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge | 1 week after last dose, post allergen challenge | — |
| Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge | 1 week after last dose, pre allergen challenge | — |
| FEV1, Early Asthmatic Response (EAR) - Pre-treatment | Pre-treatment (Baseline measurement) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD8848, 30 μg AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. | 6 |
| AZD8848, 60 μg AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. | 26 |
| Placebo Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. | 28 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Main Part | Adverse Event | 0 | 4 | 2 |
| Main Part | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | AZD8848, 30 μg | AZD8848, 60 μg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 36.3 Years | 33.0 Years | 32.3 Years | 33.9 Years |
| Sex: Female, Male Female | 0 Participants | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 19 Participants | 21 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / — | 22 / — | 24 / — |
| serious Total, serious adverse events | 0 / — | 0 / — | 1 / — |
Outcome results
Primary
FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose | 0.616 ratio | Standard Deviation 0.296 |
| Placebo | FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose | 0.970 ratio | Standard Deviation 0.641 |
Primary
FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose | 0.759 ratio | Standard Deviation 0.397 |
| Placebo | FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose | 0.722 ratio | Standard Deviation 0.584 |
Primary
FEV1, Late Asthmatic Response (LAR) - Pre-treatment
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Late Asthmatic Response (LAR) - Pre-treatment | 0.814 ratio | Standard Deviation 0.45 |
| Placebo | FEV1, Late Asthmatic Response (LAR) - Pre-treatment | 1.01 ratio | Standard Deviation 0.784 |
Secondary
FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose | 0.468 ratio | Standard Deviation 0.361 |
| Placebo | FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose | 0.624 ratio | Standard Deviation 0.362 |
Secondary
FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose | 0.510 ratio | Standard Deviation 0.24 |
| Placebo | FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose | 0.591 ratio | Standard Deviation 0.401 |
Secondary
FEV1, Early Asthmatic Response (EAR) - Pre-treatment
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848, 60 μg | FEV1, Early Asthmatic Response (EAR) - Pre-treatment | 0.524 ratio | Standard Deviation 0.241 |
| Placebo | FEV1, Early Asthmatic Response (EAR) - Pre-treatment | 0.611 ratio | Standard Deviation 0.362 |
Secondary
PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge | 0.691 mg/mL |
| Placebo | PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge | 0.340 mg/mL |
Secondary
PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge | 0.488 mg/mL |
| Placebo | PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge | 0.454 mg/mL |
Secondary
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge | 0.326 mg/mL |
| Placebo | PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge | 0.508 mg/mL |
Secondary
PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.468 mg/mL |
| Placebo | PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.504 mg/mL |
Secondary
PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge | 0.425 mg/mL |
| Placebo | PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge | 0.364 mg/mL |
Secondary
PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge
PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge | 0.564 mg/mL |
| Placebo | PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge | 0.609 mg/mL |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge | 0.94 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge | 0.82 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge | 0.18 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge | 0.23 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge | 1.0 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge | 0.96 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.13 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.21 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge | 0.64 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge | 0.81 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge | 0.13 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge | 0.12 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge | 0.067 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge | 0.071 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge | 0.11 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge | 0.045 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge | 0.037 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge | 0.082 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.045 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.054 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge | 0.078 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge | 0.073 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge | 0.045 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge | 0.053 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge | 0.79 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge | 0.82 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge | 0.60 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge | 0.75 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge | 0.68 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge | 0.67 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.54 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.95 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge | 0.86 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge | 0.68 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge | 3.0 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge | 2.8 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge | 1.3 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge | 1.8 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge | 2.5 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge | 3.1 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.3 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.6 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge | 3.0 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge | 3.1 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge | 45 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge | 37 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge | 37 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge | 36 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge | 72 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge | 41 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge | 29 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge | 43 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge | 41 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge | 44 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge | 7.8 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge | 5.4 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge | 0.82 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge | 1.3 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge | 5.7 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge | 8.0 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.2 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.7 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge | 7.1 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge | 5.8 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge | 26 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge | 23 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge | 15 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge | 9.6 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge | 20 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge | 29 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge | 12 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge | 21 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge | 28 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge | 27 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge | 1272 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge | 1270 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge | 720 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge | 609 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge | 1500 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge | 1304 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge | 496 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge | 1012 pg/mL |
Secondary
Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge | 1300 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge | 1450 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge | 0.57 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge | 0.63 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge | 1.3 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge | 1.4 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge | 37 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge | 23 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge | 0.83 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge | 0.87 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge | 15 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge | 9.4 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge | 766 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge | 522 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge | 0.003 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge | 0.003 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge | 0.002 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge | 0.003 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge | 0.005 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge | 0.003 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.005 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.005 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge | 0.008 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge | 0.004 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge | 0.004 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge | 0.004 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge | 1.0 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge | 0.77 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge | 0.80 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge | 0.36 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge | 0.56 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge | 0.74 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.47 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.58 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge | 1.1 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge | 0.60 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge | 1.1 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge | 0.59 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge | 2.1 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge | 1.7 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge | 1.5 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge | 0.91 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge | 2.6 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge | 1.6 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 0.80 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.3 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge | 1.9 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge | 1.5 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge | 0.75 10^6 cells/g |
| Placebo | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge | 0.93 10^6 cells/g |
Secondary
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge | 11 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge | 8.4 pg/mL |
Secondary
Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge | 6.5 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge | 5.3 pg/mL |
Secondary
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge | 13 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge | 7.9 pg/mL |
Secondary
Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge | 5.1 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge | 9.4 pg/mL |
Secondary
Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge | 13 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge | 12 pg/mL |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge | 5.0 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge | 4.2 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge | 3.7 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge | 3.0 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge | 5.2 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge | 4.0 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge | 1.9 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge | 2.6 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge | 5.0 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge | 3.5 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge | 2.7 Cell count/g |
| Placebo | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge | 2.7 Cell count/g |
Secondary
Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848, 60 μg | Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge | 8.9 pg/mL |
| Placebo | Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge | 4.8 pg/mL |