NCT00354042

Brief Summary

This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 asthma

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

First QC Date

July 18, 2006

Last Update Submit

May 15, 2009

Conditions

Asthma

Keywords

GW597901XAsthmaCrossoverdose ascendingrepeat doseinhaled

Outcome Measures

Primary Outcomes (1)

  • Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.

Secondary Outcomes (1)

  • Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.

Interventions

GW597901XDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with mild to moderate stable asthma but no other lung problems.
  • Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
  • Non-Smokers.
  • Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.

You may not qualify if:

  • Any significant illness.
  • Subjects with heart problems.
  • Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
  • Subjects who take medication for their asthma, or other conditions, not compatible with this study.
  • Subjects who are over sensitive to salbutamol or to ipratropium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaRespiratory Aspiration

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, MD, MSc, FPPM

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

August 1, 2004

Last Updated

May 18, 2009

Record last verified: 2009-05