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OpenTrials
Completed

NCT Number: NCT00404586

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

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

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW784568X

Drug

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 propionate

Drug

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

Placebo

Drug

Matching Placebo to GW784568X as aqueous nasal spray.

Primary outcomes

  1. Nasal symptom scores after 7 days of dosing

    Time frame: after 7 days of dosing

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 29, 2006
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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