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NCT00468975 Clinical Trial

A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00468975
Other study ID # A7881004
Secondary ID
Status Completed
Phase Phase 2
First received May 2, 2007
Last updated October 27, 2010
Start date May 2007

Study information
Verified date October 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Unknown:
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-610,355

• Salmeterol

Locations
Country Name City State
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Großhansdorf
Germany Pfizer Investigational Site Wiesbaden
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Lund
United Kingdom Pfizer Investigational Site Manchester

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Germany,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak and Trough (24 hour post dose) FEV1.
Secondary Peak and trough (24 hour post dose) PEFR
Secondary FEV1 and PEFR measurements to 32 hours post dose.
Secondary Pharmacokinetics of PF-610,355 and salmeterol
Secondary Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
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