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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00468975

First received: May 2, 2007

Last updated: October 27, 2010

Last verified: October 2010

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Salmeterol Salmeterol xinafoate

U.S. FDA Resources

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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
Pfizer Investigational Site
Berlin, Germany, 14050
Pfizer Investigational Site
Großhansdorf, Germany, 22927
Pfizer Investigational Site
Wiesbaden, Germany, 65187
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Lund, Sweden, 221 85
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

Additional Information:

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


ClinicalTrials.gov Identifier:	NCT00468975 History of Changes
Other Study ID Numbers:	A7881004
Study First Received:	May 2, 2007
Last Updated:	October 27, 2010

Additional relevant MeSH terms:


Salmeterol Xinafoate Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents	Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017

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