Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848
NCT ID: NCT01185080
Last Updated: 2016-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2010-09-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1. AZD8848
20 μg AZD8848 three times weekly
AZD8848
Nasal spray solution, intranasal, three times weekly for one month
2. Placebo
Placebo three times weekly
Placebo
Nasal spray solution, intranasal, three times weekly for one month
3. AZD8848 and placebo
60 μg AZD8848 once weekly and placebo twice weekly
AZD8848 and placebo
Nasal spray solution, intranasal, three times weekly for one month
Interventions
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AZD8848
Nasal spray solution, intranasal, three times weekly for one month
Placebo
Nasal spray solution, intranasal, three times weekly for one month
AZD8848 and placebo
Nasal spray solution, intranasal, three times weekly for one month
Eligibility Criteria
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Inclusion Criteria
* 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
* Family history of autoimmune disease A history of asthma
18 Years
55 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lennart Greiff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University Hospital, Sweden
Sam Lindgren, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca R&D Lund, Sweden
Locations
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Research Site
Lund, Malmohus Lan, Sweden
Research Site
Helsingborg, , Sweden
Countries
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References
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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.
Related Links
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Other Identifiers
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2010-020747-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D0540C00014
Identifier Type: -
Identifier Source: org_study_id
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