Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354042

Enrollment

Registered

2006-07-20

Start date

2004-08-31

Completion date

Unknown

Last updated

2009-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled

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).

Interventions

DRUGGW597901X

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026