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

NCT ID: NCT00354042

Last Updated: 2009-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

GW597901X

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, MD, MSc, FPPM

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

B2A100517

Identifier Type: -

Identifier Source: org_study_id