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

GlaxoSmithKline24 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

GW597901XDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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