Last updated: 11/04/2018 05:43:09

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

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GSK study ID
BGS105049
See study documents
Clinicaltrials.gov ID
NCT00404586
EudraCT ID
2006-002925-21
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Nasal symptom scores after 7 days of dosing

Timeframe: 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

Timeframe: on Day 7 and Day 8

Interventions:
Drug: GW784568X
Drug: Fluticasone propionate
Drug: Placebo
Enrollment:
45
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Perennial
Product
GW784568, fluticasone propionate
Collaborators
Not applicable
Study date(s)
September 2006 to January 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
No
  • Healthy with exception of seasonal rhinitis. May also have mild asthma.
  • Weight greater than or equal to 50kg
  • History of frequent nosebleeds
  • Have participated in another trial in the last 30 days.
Inclusion and exclusion criteria
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

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-16-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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