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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354042
• Other study ID #: B2A100517
• Status: Completed
• Phase: Phase 1
• First received: July 18, 2006
• Last updated: May 15, 2009
• Start date: August 2004

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW597901X

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
Secondary	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.