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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD8848 (30 μg PILOT part and 60 μg MAIN part) |
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| 2 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8848 | Drug | Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment (Baseline measurement) |
| 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. | 1 week after last dose |
| 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. | 4 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment (Baseline measurement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif Eriksson, MD | AstraZeneca R&D Lund | Study Director |
| Brian Leaker, MD | Respiratory Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31856838 | Derived | Leaker BR, Singh D, Lindgren S, Almqvist G, Eriksson L, Young B, O'Connor B. Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study. Respir Res. 2019 Dec 19;20(1):288. doi: 10.1186/s12931-019-1252-2. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD8848, 30 μg | AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. |
| FG001 | AZD8848, 60 μg | AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. |
| FG002 | Placebo | Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pilot Part |
| |||||||||||||
| Main Part |
|
AZD8848 30 μg nasal spray was only done in Pilot part. 3 of the 28 placebo subjects were from the PILOT part and 25 placebo subjects were from the MAIN part.
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD8848, 30 μg | AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. |
| BG001 | AZD8848, 60 μg | AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | Pre-treatment (Baseline measurement) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD8848, 30 μg | AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillitis Bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TINNITUS | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| C000609563 | AZD8848 |
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| Placebo |
| Drug |
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total. |
|
| 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. |
| 1 week after last dose |
| 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. | 4 weeks after last dose |
| PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | Pre-treatment, pre allergen challenge |
| PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | Pre-treatment, post allergen challenge |
| PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | 1 week after last dose, pre allergen challenge |
| PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | 1 week after last dose, post allergen challenge |
| PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | 4 weeks after last dose, pre allergen challenge |
| PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | 4 weeks after last dose, post allergen challenge |
| 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 - 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, 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, Lymphocytes - 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 |
| Manchester |
| United Kingdom |
| NOT COMPLETED |
|
|
| BG002 | Placebo | Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | AZD8848, 60 μg | AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. |
| OG002 | Placebo | Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. |
|
|
| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | 1 week after last dose |
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| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | 4 weeks after last dose |
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| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | Pre-treatment (Baseline measurement) |
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| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | 1 week after last dose |
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| 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. | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Mean | Standard Deviation | ratio | 4 weeks after last dose |
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| Secondary | PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge | PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | Pre-treatment, post allergen challenge |
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| 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 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | 1 week after last dose, pre allergen challenge |
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| 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 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | 1 week after last dose, post allergen challenge |
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| 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 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | 4 weeks after last dose, pre allergen challenge |
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| 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 | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | mg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | pg/mL | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | Cell count/g | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | Pre-treatment, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 1 week after last dose, post allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, pre allergen challenge |
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| Secondary | Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge | There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure. | Posted | Geometric Mean | Full Range | 10^6 cells/g | 4 weeks after last dose, post allergen challenge |
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|
|
| 0 |
| 6 |
| EG001 | AZD8848, 60 μg | AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. | 0 | 22 |
| EG002 | Placebo | Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. | 1 | 24 |
| Eye Pruritus | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| LACRIMATION INCREASED | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| EYE SWELLING | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| GLOSSODYNIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| SWOLLEN TONGUE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA 13.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
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| ALLERGY TO ARTHROPOD BITE | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL VESTIBULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| FACE INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| LETHARGY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| SPUTUM DISCOLOURED | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL MUCOSAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL SEPTUM ULCERATION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| UPPER AIRWAY OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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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