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

NCT ID: NCT00354666

Last Updated: 2016-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2004-12-31

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GSK159797

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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B2E101312

Identifier Type: -

Identifier Source: org_study_id

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