NCT00549497

Brief Summary

GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1 asthma

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 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

October 24, 2007

Last Update Submit

February 2, 2017

Conditions

Asthma

Keywords

GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin

Outcome Measures

Primary Outcomes (1)

  • Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing

    3 days

Secondary Outcomes (9)

  • Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function

    3 days

  • Total urinary free cortisol excretion

    over 24 hours on Day 1 and Day 3.

  • Serum osteocalcin weighted mean

    over 24 hours on Day 3.

  • Fasting glucose

    on Day 1

  • mRNA steroid responsive gene panel

    3 days

  • +4 more secondary outcomes

Study Arms (1)

GW870086X

OTHER
Drug: GW870086X

Interventions

GW870086XDRUG
GW870086X

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects
  • Liver function tests normal
  • years old
  • Non smoker
  • Can provide written informed consent
  • Available to complete the whole trial
  • Can use the inhalation device correctly
  • Able to read, understand and write English

You may not qualify if:

  • Deemed suitable healthy subject
  • History to sensitivity to the study medication
  • Any history of breathing problems in adult life
  • Participated in another trial within 30 days or 5 half-lives of the new chemical entity
  • Exposed to more than 4 new chemical entities within 12 months
  • Donated \>500 mL blood within 2 months of screening
  • Haemoglobin level \< 13g/dl
  • Use of prescription or non-prescription drugs within 7 days of first dose
  • Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4
  • Drinks more than 4 units a day or 28 units a week
  • Cannot use DISKHALER device correctly
  • Positive HepB, HepC within 3 months of screening
  • Positive HIV test
  • Positive pre study drug/alcohol screen
  • Significant cardiac conduction abnormalities
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Herston, Queensland, 4006, Australia

Location

Related Publications (1)

  • Dolle S, Hielscher N, Bareille PJ, Hardes K, Robertson J, Worm M. Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials. Skin Pharmacol Physiol. 2015;28(3):159-66. doi: 10.1159/000367696. Epub 2015 Jan 20.

    PMID: 25614148DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Aspiration

Interventions

GW870086X

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 3, 2017

Record last verified: 2011-02

Locations

AU(1)