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

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-23

Study Completion Date

2007-01-10

Brief Summary

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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.

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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

TRIPLE

Participants Caregivers Investigators

Study Groups

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GW642444

Group Type EXPERIMENTAL

GW642444 (25, 100 & 400 mcg/day)

Intervention Type DRUG

25, 100 and 400mcg/dose

Salmeterol

Group Type ACTIVE_COMPARATOR

Salmeterol 50mcg

Intervention Type DRUG

Salmeterol 50mcg

Interventions

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GW642444 (25, 100 & 400 mcg/day)

25, 100 and 400mcg/dose

Intervention Type DRUG

Salmeterol 50mcg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Wellington, , New Zealand

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

GSK Investigational Site

Stockholm, , Sweden

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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Germany New Zealand Russia Sweden United Kingdom

Study Documents

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