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A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis

NCT00612118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2012-06-05

No results posted yet for this study

Summary

This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, and allergen challenge assessments will also be performed at various time points throughout the study.

Conditions

  • Allergic Rhinitis
  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

GSK256066

200mcg bd

DRUG

azelastine hydrochloride

140mcg

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612118 on ClinicalTrials.gov