Last updated: 11/04/2018 05:34:09
Investigation Of A New Medication (GW642444) In Asthmatic Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-centre, randomised, double-blind, placebo controlled, dose ascending, four way crossover study to examine efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat doses of GW642444
Trial description: This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
FEV1 at 24 hours after a single dose.
Timeframe: 24 hours on 4 separate occasions
Secondary outcomes:
FEV1 - Days 1 and 7
Timeframe: Days 1 and 7 on 4 separate occasions
Mean morning/evening PEFR
Timeframe: Days 3-8 on 4 separate occasions
BP, HR & QTc on Days 1 and 7
Timeframe: Days 1 and 7 on 4 separate occasions
Potassium and glucose on Days 1 and 7
Timeframe: Days 1 and 7 on 4 separate occasions
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
Timeframe: throughout study
PK parameters
Timeframe: Days 1, 4 and 7 on 4 separate occasions
Interventions:
Drug: GW642444
Drug: Placebo
Drug: salmeterol 50mcg
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
January 2005 to June 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
- Non-smokers for at least 6 months.
- Abnormal findings on heart monitoring assessment.
- Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
Inclusion and exclusion criteria
Inclusion criteria:
- Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
- Non-smokers for at least 6 months.
- Stable asthma.
Exclusion criteria:
- Abnormal findings on heart monitoring assessment.
- Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
- Currently taking doses of fluticasone propionate over 500mcg/day.
- Unstable asthma medication.
Trial location(s)
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-07-06
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.
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