Last updated: 11/04/2018 05:39:39

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

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GSK study ID
B2E101312
Clinicaltrials.gov ID
NCT00354666
EudraCT ID
2004-001078-16
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK159797
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
milveterol
Collaborators
Not applicable
Study date(s)
September 2004 to December 2004
Type
Interventional
Phase
2

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 females 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 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.

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
2004-02-12

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

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