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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468975
First Posted: May 3, 2007
Last Update Posted: November 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00468975     History of Changes
Other Study ID Numbers: A7881004
First Submitted: May 2, 2007
First Posted: May 3, 2007
Last Update Posted: November 1, 2010
Last Verified: October 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