Single Doses GSK159797 On Patient Safety And Lung Functio... | NCT00354666

Studies
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

NCT00354666

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 1, 2016Estimated

Enrollment

Phase

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK159797

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

Aug 2016

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

Sep 2004

Primary Completion Date

Not provided

Completion Date

Dec 2004Actual

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

Aug 31, 2016

Last Update Posted Date

Sep 1, 2016Estimated

Description Module

Brief Summary

This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
GSK159797	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).

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 females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
Non-smokers.
Subjects that 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 had a cold or chest infection 2-4 weeks prior to the study.
Subjects who take medication for their asthma, or other conditions, not compatible with the study.

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	GlaxoSmithKline	Study Director

References Module

Citations

Not provided

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D053120	Respiratory Aspiration

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease