Trial intelligence / Profile preview

GSK256066 in Seasonal Allergic Rhinitis (Vienna Challenge Chamber)

NCT00377728Phase 2

Key facts

Status: Completed
Start: Mar 2006
Primary completion: May 2006
Countries: 1
Sponsor: GSK
Modality: Small Molecules

Drugs: GSK256066
Conditions: seasonal allergic rhinitis (SAR)

Overview

Phase 2, randomised, double-blind trial of GSK256066 in seasonal allergic rhinitis (SAR) (2 arms), sponsored by GSK. Primary endpoint: Weighted Mean Total Nasal Symptom Score. Started Mar 2006; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

GSK256066 -> Placebo
Subjects receive GSK256066 in Period 1 and Placebo in Period 2.
Placebo -> GSK256066
Subjects receive Placebo in Period 1 and GSK256066 in Period 2.

Who it enrols

Patients with a history of seasonal allergic rhinitis who exhibit a moderate response to grass pollen in the Vienna Challenge Chamber.

Endpoints

Primary

Weighted Mean Total Nasal Symptom ScoreDay 8 or 14

Secondary

Weighted Mean Nasal Airflow ResistanceDay 8 or 14
Weighted Mean Eye Symptom ScoreDay 8 or 14
Weighted Mean Global Symptom ScoreDay 8 or 14
Secretion WeightDay 8 or 14
Forced Expiratory Volume in 1 secondThroughout study
Adverse EventsThroughout study

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