Study With GW274150 In Patients With Mild Asthma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Singulair; Drug: GW274150; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273013

INO102141

Details and patient eligibility

About

This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild asthma: taking reliever medication (e.g. salbutamol) only.
• Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.

Exclusion criteria

• Recent steroid treatment.
• Significant illnesses or diseases other than asthma.

Trial design

28 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair

Sequence 2

Experimental group

Description:

Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair

Sequence 3

Experimental group

Description:

Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair

Sequence 4

Experimental group

Description:

Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair

Sequence 5

Experimental group

Description:

Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair

Sequence 6

Experimental group

Description:

Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.

Treatment:

Drug: Placebo

Drug: GW274150

Drug: Singulair