Investigation Of A New Medication (GW642444) In Asthmatic Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00354874

First received: July 18, 2006

Last updated: March 15, 2012

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 18, 2006

Last Updated Date

March 15, 2012

Start Date ^ICMJE

January 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FEV1 at 24 hours after a single dose. [ Time Frame: 24 hours on 4 separate occasions ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

FEV1 at 24 hours after a single dose.

Change History

Complete list of historical versions of study NCT00354874 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

FEV1 - Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
Mean morning/evening PEFR [ Time Frame: Days 3-8 on 4 separate occasions ] [ Designated as safety issue: No ]
BP, HR & QTc on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
Potassium and glucose on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG [ Time Frame: throughout study ] [ Designated as safety issue: No ]
PK parameters [ Time Frame: Days 1, 4 and 7 on 4 separate occasions ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

FEV1 - Days 1 and 7 Mean morning/evening PEFR BP, HR & QTc on Days 1 and 7 Potassium and glucose on Days 1 and 7 safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG PK parameters

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigation Of A New Medication (GW642444) In Asthmatic Patients

Official Title ^ICMJE

A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

Brief Summary

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: GW642444
drug

Other Name: GW642444
Drug: Placebo
placebo
Drug: salmeterol 50mcg
salmeterol

Study Arm (s)

Experimental: GW642444 50mcg
Intervention: Drug: GW642444
Experimental: GW642444 100mcg
Intervention: Drug: GW642444
Experimental: GW642444 200mcg
Intervention: Drug: GW642444
Active Comparator: salmeterol 50mcg
Intervention: Drug: salmeterol 50mcg
Placebo Comparator: placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
Non-smokers for at least 6 months.
Stable asthma.

Exclusion criteria:

Abnormal findings on heart monitoring assessment.
Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
Currently taking doses of fluticasone propionate over 500mcg/day.
Unstable asthma medication.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00354874

Other Study ID Numbers ^ICMJE

B2C101762

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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