A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Phase 2
Completed
- Conditions
- Asthma
- Registration Number
- NCT00468975
- Lead Sponsor
- Pfizer
- Brief Summary
A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).
- FEV1 greater than or equal to 60% predicted
- Stable disease for at least the previous 3 months
Exclusion Criteria
- Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
- Subjects with a history of pulmonary disease other than asthma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Peak and Trough (24 hour post dose) FEV1.
- Secondary Outcome Measures
Name Time Method FEV1 and PEFR measurements to 32 hours post dose. Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs. Pharmacokinetics of PF-610,355 and salmeterol Peak and trough (24 hour post dose) PEFR
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Manchester, United Kingdom