Investigation Of A New Medication (GW642444) In Asthmatic Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: salmeterol 50mcg; Drug: Placebo; Drug: GW642444

Study type: Interventional

Funder types: Industry

Identifiers

NCT00354874

B2C101762

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 5 patient groups, including a placebo group

GW642444 50mcg

Experimental group

Treatment:

Drug: GW642444

GW642444 100mcg

Experimental group

Treatment:

Drug: GW642444

GW642444 200mcg

Experimental group

Treatment:

Drug: GW642444

salmeterol 50mcg

Active Comparator group

Treatment:

Drug: salmeterol 50mcg

placebo

Placebo Comparator group

Treatment:

Drug: Placebo