Back to resultsA Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-610,355
Salmeterol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Peak and Trough (24 hour post dose) FEV1.
Secondary Outcome Measures
Peak and trough (24 hour post dose) PEFR
FEV1 and PEFR measurements to 32 hours post dose.
Pharmacokinetics of PF-610,355 and salmeterol
Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468975
Brief Title
A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Official Title
A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PF-610,355
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Primary Outcome Measure Information:
Title
Peak and Trough (24 hour post dose) FEV1.
Secondary Outcome Measure Information:
Title
Peak and trough (24 hour post dose) PEFR
Title
FEV1 and PEFR measurements to 32 hours post dose.
Title
Pharmacokinetics of PF-610,355 and salmeterol
Title
Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Pfizer Investigational Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881004&StudyName=A%20Blinded%20Study%20To%20Examine%20The%20Ability%20Of%20PF-610%2C355%20To%20Open%20The%20Airways%20In%20Asthmatic%20Patients.
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
We'll reach out to this number within 24 hrs