Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber

GlaxoSmithKline45 enrolled

Overview

This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis

A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Rhinitis, Allergic, Perennial

Interventions

GW784568XDRUG

GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.

Fluticasone propionateDRUG

Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.

PlaceboDRUG

Matching Placebo to GW784568X as aqueous nasal spray.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Healthy with exception of seasonal rhinitis. May also have mild asthma. * Weight greater than or equal to 50kg * Non-smoker for at least 12 months Exclusion criteria: * History of frequent nosebleeds * Have participated in another trial in the last 30 days. * Have donated blood in the previous 3 months * Have used prescription or non prescription drugs within last 7 days * Have history of alcohol/drug abuse within last 12 months * Have positive Hepatitis B or C test within 3 months of screening * Subject tested positive for HIV

Locations (1)

GSK Investigational Site

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

Nasal symptom scores after 7 days of dosing

Time frame: after 7 days of dosing

Secondary Outcomes

Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen

Time frame: on Day 7 and Day 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.