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

A Randomised, Double-blind, Placebo-controlled, Dose Ascending Crossover Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled GSK159797 Delivered by Dry Powder Inhaler in Mild to Moderate Asthmatic Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354666

Enrollment

Registered

2006-07-20

Start date

2004-09-30

Completion date

2004-12-31

Last updated

2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

inhaled, asthmatic subjects, GSK159797, safety and tolerability, efficacy, dry powder

Brief summary

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.

Interventions

DRUGGSK159797

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026