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

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: AZD8848; Drug: Placebo

• Registration Number: NCT00770003
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-03
• Study Completion: 2010-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD8848	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments	During the study
Nasal symptoms, peak nasal inspiratory flow	During the study

Secondary Outcome Measures

Name	Time	Method
Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow	During the study
Pharmacokinetics	During the study
Blood biomarkers and nasal lavage biomarkers	During the study

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden