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Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
AZD8848
Placebo
AZD8848 and placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring AZD8848, allergic rhinitis, efficacy, tolerability, safety, nasal symptoms

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

1. AZD8848

2. Placebo

3. AZD8848 and placebo

Arm Description

20 μg AZD8848 three times weekly

Placebo three times weekly

60 μg AZD8848 once weekly and placebo twice weekly

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 11, 2010
Last Updated
December 2, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01185080
Brief Title
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
AZD8848, allergic rhinitis, efficacy, tolerability, safety, nasal symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. AZD8848
Arm Type
Experimental
Arm Description
20 μg AZD8848 three times weekly
Arm Title
2. Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo three times weekly
Arm Title
3. AZD8848 and placebo
Arm Type
Experimental
Arm Description
60 μg AZD8848 once weekly and placebo twice weekly
Intervention Type
Drug
Intervention Name(s)
AZD8848
Intervention Description
Nasal spray solution, intranasal, three times weekly for one month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nasal spray solution, intranasal, three times weekly for one month
Intervention Type
Drug
Intervention Name(s)
AZD8848 and placebo
Intervention Description
Nasal spray solution, intranasal, three times weekly for one month
Primary Outcome Measure Information:
Title
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Description
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.
Title
Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)
Description
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.
Title
Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Description
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.
Title
Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)
Description
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.
Title
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Description
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.
Title
Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)
Description
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.
Title
Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Description
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.
Title
of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)
Description
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.
Secondary Outcome Measure Information:
Title
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Description
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)
Title
Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)
Description
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)
Title
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Description
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)
Title
Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)
Description
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)
Title
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma
Description
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
Title
Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Greiff, MD, PhD
Organizational Affiliation
Lund University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Lindgren, MD, PhD
Organizational Affiliation
AstraZeneca R&D Lund, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Lund
State/Province
Malmohus Lan
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26342289
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=192&filename=D0540C00014_Study_Synopsis.pdf
Description
CSR Synopsis
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=192&filename=AZD8848StudyD0540C00014ARCTIC-CSP_Redacted.pdf
Description
Protocol

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Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

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