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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: AZD8848; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770003

D0540C00003

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD8848

2

Placebo Comparator group

Treatment:

Drug: Placebo