Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00347139

First received: June 29, 2006

Last updated: May 31, 2012

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2006

Last Updated Date

May 31, 2012

Start Date ^ICMJE

May 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change from baseline in trough FEV1 after repeat dosing [ Time Frame: 14 days ]

Original Primary Outcome Measures ^ICMJE

Mean change from baseline in trough FEV1 after repeat dosing for 14 days.

Change History

Complete list of historical versions of study NCT00347139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean change in FEV1 [ Time Frame: after a single dose ]
Mean change in FEV1 after dosing [ Time Frame: 7 days ]
Weighted Mean FEV1 0-2, 0-4 and 0-24h [ Time Frame: on Day 1, Day 7, Day 14 ]
AM PEFRAM FEV1 [ Time Frame: over Days 2-15 ]
PM PEFRPM FEV1 [ Time Frame: over Days 1-14 ]

Original Secondary Outcome Measures ^ICMJE

Mean change in FEV1 after a single dose
Mean change in FEV1 after dosing for 7 days
Weighted Mean FEV1 0-2, 0-4 and 0-24h on D1 7 D14
AM PEFR over Days 2-15.
PM PEFR over Days 1-14
AM FEV1 over Days 2-15
PM FEV1 over Days 1-14

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

Official Title ^ICMJE

Multi-centre, Randomised, 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 (25, 100 and 400 Mcg Once Daily) of GW642444

Brief Summary

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.

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, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive
Asthma

Intervention ^ICMJE

Drug: GW642444 (25, 100 & 400 mcg/day)
25, 100 and 400mcg/dose
Drug: Salmeterol 50mcg
Salmeterol 50mcg

Study Arm (s)

Experimental: GW642444
N/A

Intervention: Drug: GW642444 (25, 100 & 400 mcg/day)
Active Comparator: Salmeterol
Intervention: Drug: Salmeterol 50mcg

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

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Subjects with a documented history of persistent asthma.
Current non-smokers.
Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.

Exclusion criteria:

Subjects with significant past or present disease which which may affect their safety.
Upper or lower respiratory tract infection within 4 weeks of screening.
History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
Patients weighing less than 50kg.

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, New Zealand, Russian Federation, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00347139

Other Study ID Numbers ^ICMJE

B2C106093

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

March 2011

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

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