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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:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354042
First received: July 18, 2006
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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
Intervention Details:
    Drug: GW597901X
    Other Name: GW597901X
  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354042

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00354042     History of Changes
Other Study ID Numbers: B2A100517
Study First Received: July 18, 2006
Last Updated: May 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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 16, 2013