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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

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
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:
No publications provided

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
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 20, 2014