Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-02-28

Brief Summary

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The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.

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Detailed Description

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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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

nasal spray solution. Once weekly intranasal administrations for one month.

Interventions

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AZD8848

nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month

Intervention Type DRUG

Placebo

nasal spray solution. Once weekly intranasal administrations for one month.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a history 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

* Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
* Symptomatic perennial allergic or non-allergic rhinitis
* A history of asthma

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No