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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404586

Enrollment

Registered

2006-11-29

Start date

2006-09-11

Completion date

2007-01-16

Last updated

2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

Environmental Challenge Chamber, GW784568X, Intranasal

Brief summary

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

Detailed description

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

Interventions

DRUGGW784568X

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.

DRUGFluticasone propionate

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

DRUGPlacebo

Matching Placebo to GW784568X as aqueous nasal spray.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Nasal symptom scores after 7 days of dosing	after 7 days of dosing

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026