Allergic Rhinitis
Conditions
Keywords
AZD8848, allergic rhinitis, efficacy, tolerability, safety, nasal symptoms
Brief summary
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.
Detailed description
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
Interventions
DRUGAZD8848
Nasal spray solution, intranasal, three times weekly for one month
DRUGPlacebo
Nasal spray solution, intranasal, three times weekly for one month
DRUGAZD8848 and placebo
Nasal spray solution, intranasal, three times weekly for one month
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Seasonal allergic rhinitis patients out of pollen season * Have a history and presence of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) * Patients with need of treatment for their nasal symptoms during the pollen season
Exclusion criteria
* Symptomatic perennial allergic or non-allergic rhinitis * Family history of autoimmune disease A history of asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. | 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). |
| Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. | 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). |
| Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | During the evening of the 1st day to the morning of the 8th day of Allergen challenge period. | 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). |
| Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | During 1st day to 7th day of Allergen challenge period. | 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). |
| Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | During evening of the 1st day to the morning of the 8th day of Allergen challenge period. | 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). |
| Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | During 1st day to 7th day of Allergen challenge period. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | Pre-dose on visit 2 (baseline) | 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. |
| Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | Baseline to 1st day of visit 15 | 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. |
| Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | Baseline to 1st day of visit 15 | 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. |
| Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | Pre-dose on visit 2 (baseline) | 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. |
Countries
Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AZD8848 20 μg x3 20 μg AZD8848 three times weekly | 50 |
| Placebo Placebo three times weekly | 16 |
| AZD8848 60 μg 60 μg AZD8848 once weekly and placebo twice weekly | 17 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Personal reasons | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AZD8848 20 μg x3 | Placebo | AZD8848 60 μg | Total |
|---|---|---|---|---|
| Age, Continuous | 29.7 years | 28.8 years | 31.0 years | 29.8 years |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 44 Participants | 14 Participants | 15 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 50 | 12 / 16 | 12 / 17 |
| serious Total, serious adverse events | 0 / 50 | 0 / 16 | 0 / 17 |
Outcome results
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).
Time frame: During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 2.06 Scores on a scale |
| Placebo | Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 2.32 Scores on a scale |
| AZD8848 60 μg | Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 1.96 Scores on a scale |
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).
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 136 L/min |
| Placebo | Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 148 L/min |
| AZD8848 60 μg | Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 148 L/min |
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).
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 1.81 Scores on a scale |
| Placebo | Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 2.14 Scores on a scale |
| AZD8848 60 μg | Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS) | 1.48 Scores on a scale |
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).
Time frame: During 1st day to 7th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 117 L/min |
| Placebo | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 127 L/min |
| AZD8848 60 μg | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 129 L/min |
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).
Time frame: During 4th day to 7th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 121 L/min |
| Placebo | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 128 L/min |
| AZD8848 60 μg | Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min) | 135 L/min |
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).
Time frame: During 1st day to 7th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 4.52 Scores on a scale |
| Placebo | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 4.97 Scores on a scale |
| AZD8848 60 μg | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 4.69 Scores on a scale |
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).
Time frame: During 4th day to 7th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 4.45 Scores on a scale |
| Placebo | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 5.36 Scores on a scale |
| AZD8848 60 μg | Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS) | 4.42 Scores on a scale |
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).
Time frame: During evening of the 1st day to the morning of the 8th day of Allergen challenge period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 145 L/min |
| Placebo | of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 149 L/min |
| AZD8848 60 μg | of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs) | 147 L/min |
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.
Time frame: Pre-dose on visit 2 (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848 20 μg x3 | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 0.38 Scores on a scale | Standard Deviation 0.697 |
| Placebo | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 0.75 Scores on a scale | Standard Deviation 1.291 |
| AZD8848 60 μg | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 0.35 Scores on a scale | Standard Deviation 0.493 |
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.
Time frame: Pre-dose on visit 11 (end of 3rd week of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848 20 μg x3 | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 1.20 Scores on a scale | Standard Deviation 1.02 |
| Placebo | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 0.67 Scores on a scale | Standard Deviation 1.047 |
| AZD8848 60 μg | Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS) | 0.80 Scores on a scale | Standard Deviation 0.862 |
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.
Time frame: Pre-dose on visit 11 (end of 3rd week of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848 20 μg x3 | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 168.1 L/min | Standard Deviation 52.07 |
| Placebo | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 191.3 L/min | Standard Deviation 48.824 |
| AZD8848 60 μg | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 182.7 L/min | Standard Deviation 61.35 |
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.
Time frame: Pre-dose on visit 2 (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD8848 20 μg x3 | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 170.4 L/min | Standard Deviation 54.593 |
| Placebo | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 176.9 L/min | Standard Deviation 63.005 |
| AZD8848 60 μg | Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF) | 169.4 L/min | Standard Deviation 62.497 |
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.
Time frame: Baseline to 1st day of visit 15
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | 30.0 ratio |
| Placebo | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | 1.66 ratio |
| AZD8848 60 μg | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage | 26.9 ratio |
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.
Time frame: Baseline to 1st day of visit 15
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD8848 20 μg x3 | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | 2.89 ratio |
| Placebo | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | 0.803 ratio |
| AZD8848 60 μg | Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma | 3.90 ratio |