Last updated: 11/04/2018 05:33:20
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
GSK study ID
B2A100517
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW597901X
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
GW597901
Collaborators
Not applicable
Study date(s)
August 2004 to January 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
no
- 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).
- Any significant illness.
- Subjects with heart problems.
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-28-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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