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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00468975

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: PF-610,355 Drug: Salmeterol	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

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.

Estimated Enrollment:	42
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468975

Locations

Germany
Pfizer Investigational Site
Wiesbaden, Germany, 65187
Pfizer Investigational Site
Großhansdorf, Germany, 22927
Pfizer Investigational Site
Berlin, Germany, 14050
Sweden
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Goteborg, Sweden, 413 45
United Kingdom
Pfizer Investigational Site
Manchester, United Kingdom, M23 9QZ

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A7881004
Study First Received:	May 2, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00468975
Health Authority:	Unknown:

Study placed in the following topic categories:

Salmeterol
Asthma

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009