Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

NCT ID: NCT01185080

Last Updated: 2016-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. AZD8848

20 μg AZD8848 three times weekly

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

Nasal spray solution, intranasal, three times weekly for one month

2. Placebo

Placebo three times weekly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Nasal spray solution, intranasal, three times weekly for one month

3. AZD8848 and placebo

60 μg AZD8848 once weekly and placebo twice weekly

Group Type EXPERIMENTAL

AZD8848 and placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Nasal spray solution, intranasal, three times weekly for one month

Intervention Type DRUG

AZD8848 and placebo

Nasal spray solution, intranasal, three times weekly for one month

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Research Site

Helsingborg, , Sweden

Site Status

Countries

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Sweden

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.

Reference Type DERIVED
PMID: 26342289 (View on PubMed)

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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