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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020747-13 | EudraCT Number |
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The primary purpose of this study is to investigate effect, tolerability and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of season in an allergen challenge model.
A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. AZD8848 | Experimental | 20 μg AZD8848 three times weekly |
|
| 2. Placebo | Placebo Comparator | Placebo three times weekly |
|
| 3. AZD8848 and placebo | Experimental | 60 μg AZD8848 once weekly and placebo twice weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8848 | Drug | Nasal spray solution, intranasal, three times weekly for one month |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During 1st day to 7th day of Allergen challenge period. |
| Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During 4th day to 7th day of Allergen challenge period. |
| Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lennart Greiff, MD, PhD | Lund University Hospital, Sweden | Principal Investigator |
| Sam Lindgren, MD, PhD | AstraZeneca R&D Lund, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Lund | Malmohus Lan | Sweden | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26342289 | Derived | Greiff L, Ahlstrom-Emanuelsson C, Alenas M, Almqvist G, Andersson M, Cervin A, Dolata J, Lindgren S, Martensson A, Young B, Widegren H. Biological effects and clinical efficacy of a topical Toll-like receptor 7 agonist in seasonal allergic rhinitis: a parallel group controlled phase IIa study. Inflamm Res. 2015 Nov;64(11):903-15. doi: 10.1007/s00011-015-0873-2. Epub 2015 Sep 5. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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There were 93 patients enrolled in the study, who 83 of them were randomized. Of the 10 patients who were not randomized, 3 patients due to "patient decision" and 7 patients due to "Eligibility criteria not fulfilled" were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD8848 20 μg x3 | 20 μg AZD8848 three times weekly |
| FG001 | Placebo | Placebo three times weekly |
| FG002 | AZD8848 60 μg | 60 μg AZD8848 once weekly and placebo twice weekly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD8848 20 μg x3 | 20 μg AZD8848 three times weekly |
| BG001 | Placebo | Placebo three times weekly |
| 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 | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | Scores on a scale | During 1st day to 7th day of Allergen challenge period. |
|
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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 20 μg x3 | 20 μg AZD8848 three times weekly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pruritus | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C000609563 | AZD8848 |
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| Placebo |
| Drug |
Nasal spray solution, intranasal, three times weekly for one month |
|
| AZD8848 and placebo | Drug | Nasal spray solution, intranasal, three times weekly for one month |
|
| During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
| Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During the evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
| Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During 1st day to 7th day of Allergen challenge period. |
| Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During 4th day to 7th day of Allergen challenge period. |
| Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
| of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
| Pre-dose on visit 2 (baseline) |
| Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11. | Pre-dose on visit 11 (end of 3rd week of treatment) |
| Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2. | Pre-dose on visit 2 (baseline) |
| Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11. | Pre-dose on visit 11 (end of 3rd week of treatment) |
| Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15. | Baseline to 1st day of visit 15 |
| Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15. | Baseline to 1st day of visit 15 |
| Helsingborg |
| Sweden |
| Protocol | View source |
| BG002 |
| AZD8848 60 μg |
60 μg AZD8848 once weekly and placebo twice weekly |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
20 μg AZD8848 three times weekly |
| OG001 | Placebo | Placebo three times weekly |
| OG002 | AZD8848 60 μg | 60 μg AZD8848 once weekly and placebo twice weekly |
|
|
| Primary | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | Scores on a scale | During 4th day to 7th day of Allergen challenge period. |
|
|
|
| Primary | Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | Scores on a scale | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
|
|
|
| Primary | Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | Scores on a scale | During the evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
|
|
|
| Primary | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | L/min | During 1st day to 7th day of Allergen challenge period. |
|
|
|
| Primary | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | L/min | During 4th day to 7th day of Allergen challenge period. |
|
|
|
| Primary | Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | L/min | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
|
|
|
| Primary | of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15). | Posted | Least Squares Mean | Full Range | L/min | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. |
|
|
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| Secondary | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2. | Posted | Mean | Standard Deviation | Scores on a scale | Pre-dose on visit 2 (baseline) |
|
|
|
| Secondary | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11. | Posted | Mean | Standard Deviation | Scores on a scale | Pre-dose on visit 11 (end of 3rd week of treatment) |
|
|
|
| Secondary | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2. | Posted | Mean | Standard Deviation | L/min | Pre-dose on visit 2 (baseline) |
|
|
|
| Secondary | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11. | Posted | Mean | Standard Deviation | L/min | Pre-dose on visit 11 (end of 3rd week of treatment) |
|
|
|
| Secondary | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline to 1st day of visit 15 |
|
|
|
| Secondary | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline. Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15. | Posted | Least Squares Mean | 95% Confidence Interval | ratio | Baseline to 1st day of visit 15 |
|
|
|
| 0 |
| 50 |
| 48 |
| 50 |
| EG001 | Placebo | Placebo three times weekly | 0 | 16 | 12 | 16 |
| EG002 | AZD8848 60 μg | 60 μg AZD8848 once weekly and placebo twice weekly | 0 | 17 | 12 | 17 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Disgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Herpes Virus Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Eczema Eyelids | Eye disorders | Systematic Assessment |
|
| Eye Oedema | Eye disorders | Systematic Assessment |
|
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
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |