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Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354042
First Posted: July 20, 2006
Last Update Posted: May 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  Purpose
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).

Condition Intervention Phase
Asthma Drug: GW597901X Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.

Estimated Enrollment: 24
Study Start Date: August 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with mild to moderate stable asthma but no other lung problems.
  • Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
  • Non-Smokers.
  • Subjects who 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 a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
  • Subjects who take medication for their asthma, or other conditions, not compatible with this study.
  • Subjects who are over sensitive to salbutamol or to ipratropium.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354042


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00354042     History of Changes
Other Study ID Numbers: B2A100517
First Submitted: July 18, 2006
First Posted: July 20, 2006
Last Update Posted: May 18, 2009
Last Verified: May 2009

Keywords provided by GlaxoSmithKline:
GW597901X
Asthma
Crossover
dose ascending
repeat dose
inhaled

Additional relevant MeSH terms:
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action