Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo; Drug: AZD8848; Drug: AZD8848 and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01185080

D0540C00014

2010-020747-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 93 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 3 patient groups, including a placebo group

1. AZD8848

Experimental group

Description:

20 μg AZD8848 three times weekly

Treatment:

Drug: AZD8848

2. Placebo

Placebo Comparator group

Description:

Placebo three times weekly

Treatment:

Drug: Placebo

3. AZD8848 and placebo

Experimental group

Description:

60 μg AZD8848 once weekly and placebo twice weekly

Treatment:

Drug: AZD8848 and placebo