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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354666
• Other study ID #: B2E101312
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: August 31, 2016
• Start date: September 2004
• Est. completion date: December 2004

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK159797

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.
Secondary	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).

External Links

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