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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00404586
First received: November 27, 2006
Last updated: October 15, 2008
Last verified: October 2008

November 27, 2006
October 15, 2008
September 2006
Not Provided
Nasal symptom scores after 7 days of dosing [ Time Frame: after 7 days of dosing ]
Nasal symptom scores after 7 days of dosing
Complete list of historical versions of study NCT00404586 on ClinicalTrials.gov Archive Site
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 ]
  • Nasal symptom scores
  • Eye symptom scores
  • Other symptom scores
  • Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
Not Provided
Not Provided
 
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
See Detailed Description

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Allergic Rhinitis
Drug: GW784568X
Other Name: GW784568X
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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Not Provided

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00404586
BGS105049
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP