Status:
COMPLETED
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) conta...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
- screening pre-bronchodilator FEV1 \>or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \>or= 12.0% over the max of the three screening measures and an absolute change of
- \>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
- BMI 19-31 kg/m2,
- Non-smoker,
- refrains from use of prohibited medication within the specified timeframes
- Exclusion criteria:
- Pregnant or nursing females
- History of life threatening asthma
- Subjects who are unable to stop taking protocol defined prohibited medication
Exclusion
Key Trial Info
Start Date :
February 17 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00444509
Start Date
February 17 2007
End Date
April 9 2007
Last Update
August 4 2017
Active Locations (1)
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1
GSK Investigational Site
Wellington, New Zealand, 6035