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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Asthma

Treatments

Drug: GW597901X

Study type

Interventional

Funder types

Industry

Identifiers

NCT00354042
B2A100517

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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