Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: salbutamol; Drug: salmeterol 50mcg; Drug: placebo; Drug: GSK159797 (10, 15, and 20mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358488

B2E106359

Details and patient eligibility

About

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
• Female subjects only using acceptable birth control method
• Non-smokers
• FEV1 between 60 and 90% predicted
• Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria

• Past or present disease conditions
• Normal screening Holter ECG
• Respiratory tract infection within 4 weeks of screening
• History of life threatening asthma
• Previous use of COA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 4 patient groups, including a placebo group

GSK159797 (10, 15, and 20mcg)

Experimental group

Description:

GSK159797 (10, 15, and 20mcg)

Treatment:

Drug: GSK159797 (10, 15, and 20mcg)

salbutamol

Experimental group

Description:

salbutamol

Treatment:

Drug: salbutamol

salmeterol 50mcg

Experimental group

Description:

salmeterol 50mcg

Treatment:

Drug: salmeterol 50mcg

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo