Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

GlaxoSmithKline20 enrolled

Overview

This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK159797DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Subjects with mild to moderate stable asthma but no other lung problems. * Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile). * Non-smokers. * Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol. Exclusion criteria: * Any significant illness. * Subjects with heart problems. * Subjects who have had a cold or chest infection 2-4 weeks prior to the study. * Subjects who take medication for their asthma, or other conditions, not compatible with the study.

Outcomes

Primary Outcomes

Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

Secondary Outcomes

Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.