Efficacy study in allergic rhinitis patients after intranasal administration of AZD8848

Study identifier:D0540C00014

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-020747-13

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Allergic Rhinitis

Phase

Phase 2

Healthy volunteers

Study drug

AZD8848, Placebo, AZD8848 and placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Sept 2010

Primary Completion Date: 01 Dec 2010

Study Completion Date: 01 Jan 2012

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2015 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Lund, Malmohus Lan, Sweden

Location

Research Site

HELSINGBORG, Sweden

Arms	Assigned Interventions
Experimental: 1. AZD8848 20 μg AZD8848 three times weekly	Drug: AZD8848 Nasal spray solution, intranasal, three times weekly for one month
Placebo Comparator: 2. Placebo Placebo three times weekly	Drug: Placebo Nasal spray solution, intranasal, three times weekly for one month
Experimental: 3. AZD8848 and placebo 60 μg AZD8848 once weekly and placebo twice weekly	Drug: AZD8848 and placebo Nasal spray solution, intranasal, three times weekly for one month

Documents available

CSR Synopsis
Download
Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Lennart Greiff

Lund University Hospital, Sweden

Efficacy study in allergic rhinitis patients after intranasal administration of AZD8848

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

CSR Synopsis

Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator