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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354666
First received: July 18, 2006
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: GSK159797
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 20
Study Start Date: September 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK159797
    Other Name: GSK159797
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354666

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00354666     History of Changes
Other Study ID Numbers: B2E101312
Study First Received: July 18, 2006
Last Updated: October 1, 2010
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:
GSK159797
efficacy
safety and tolerability
 inhaled
dry powder
asthmatic subjects

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013