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OpenTrials
Completed

NCT Number: NCT00354666

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK159797

Drug

Primary outcomes

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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
Jul 20, 2006
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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