NCT00404586

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2007

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

November 27, 2006

Last Update Submit

September 11, 2017

Conditions

Rhinitis, Allergic, Perennial

Keywords

Environmental Challenge ChamberGW784568XIntranasal

Outcome Measures

Primary Outcomes (1)

  • Nasal symptom scores after 7 days of dosing

    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

    on Day 7 and Day 8

Study Arms (4)

Treatment period 1

EXPERIMENTAL

In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.

Drug: GW784568XDrug: Fluticasone propionate

Treatment period 2

EXPERIMENTAL

In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.

Drug: GW784568XDrug: Fluticasone propionate

Treatment period 3

EXPERIMENTAL

In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.

Drug: GW784568XDrug: Fluticasone propionate

Treatment period 4

PLACEBO COMPARATOR

In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.

Drug: Fluticasone propionateDrug: Placebo

Interventions

GW784568XDRUG

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.

Treatment period 1Treatment period 2Treatment period 3
Fluticasone propionateDRUG

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

Treatment period 1Treatment period 2Treatment period 3Treatment period 4
PlaceboDRUG

Matching Placebo to GW784568X as aqueous nasal spray.

Treatment period 4

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

September 11, 2006

Primary Completion

January 16, 2007

Study Completion

January 16, 2007

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

DE(1)