Effects Of Repeat Inhaled Doses Of GW597901X On Patient S... | NCT00354042

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

NCT00354042

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 18, 2009Estimated

Enrollment

Phase

Phase 1

Conditions

Asthma

Interventions

GW597901X

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 18, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2009

Last Update Posted Date

May 18, 2009Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
GW597901X	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials, MD, MSc, FPPM	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided