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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: GW642444 (25, 100 & 400 mcg/day)

Drug: Salmeterol 50mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347139

B2C106093

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.