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

Rhinitis, Allergic, Perennial Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404586
• Other study ID #: BGS105049
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2006
• Last updated: September 11, 2017
• Start date: September 11, 2006
• Est. completion date: January 16, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 16, 2007
• Est. primary completion date: January 16, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• GW784568X
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
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
• Placebo
Matching Placebo to GW784568X as aqueous nasal spray.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal symptom scores after 7 days of dosing		after 7 days of dosing
Secondary	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

External Links

•   Results for study BGS105049 can be found on the GSK Clinical Study Register.