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

AstraZeneca103 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

103

Conditions

Allergic Rhinitis

Interventions

AZD8848DRUG

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

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Helsingborg, Sweden

Research Site

Lund, Sweden

Outcomes

Primary Outcomes

Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments

Time frame: During the study

Nasal symptoms, peak nasal inspiratory flow

Time frame: During the study

Secondary Outcomes

Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow

Time frame: During the study

Blood biomarkers and nasal lavage biomarkers

Time frame: During the study

Pharmacokinetics

Time frame: During the study

Data from ClinicalTrials.gov

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