Study Investigating Repeat Doses Of A New Medication (GSK... | NCT00358488

Studies
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

NCT00358488

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

54Actual

Phase

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK159797 (10, 15, and 20mcg)
salbutamol
salmeterol 50mcg
placebo

Countries

Germany
Netherlands
Russia
Sweden
United Kingdom

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797

Status Module

Record Verification Date

Oct 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

Apr 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Jul 27, 2006

First Submission Date that Met QC Criteria

Jul 27, 2006

First Posted Date

Jul 31, 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

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Description Module

Brief Summary

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK159797 (10, 15, and 20mcg)	Experimental	GSK159797 (10, 15, and 20mcg)	Drug: GSK159797 (10, 15, and 20mcg)
salbutamol	Experimental	salbutamol	Drug: salbutamol
salmeterol 50mcg	Experimental	salmeterol 50mcg	Drug: salmeterol 50mcg
placebo	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK159797 (10, 15, and 20mcg)	Drug	GSK159797 (10, 15, and 20mcg)	GSK159797 (10, 15, and 20mcg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in trough FEV1		after 14 day repeat doses

Secondary Outcomes

Measure	Description	Time Frame
Mean change from baseline in trough FEV1		after a single dose
Mean change from baseline in trough FEV1		after 7 days repeat dosing
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
Female subjects only using acceptable birth control method
Non-smokers
FEV1 between 60 and 90% predicted
Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

Past or present disease conditions
Normal screening Holter ECG
Respiratory tract infection within 4 weeks of screening
History of life threatening asthma
Previous use of COA

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Wiesbaden	Hesse	65187	Germany
GSK Investigational Site

References Module

Citations

Not provided

Type	Date	Date Unknown
Release	Apr 19, 2017
Reset	Jul 7, 2017
Release	Jul 17, 2017
Reset	Feb 2, 2018
Release	Feb 14, 2018
Unrelease	Aug 15, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 19, 2017			Jul 7, 2017
Jul 17, 2017

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

ID	Term
D000420	Albuterol
D000068299	Salmeterol Xinafoate

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals