- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468975
A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
October 27, 2010 updated by: Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 14050
- Pfizer Investigational Site
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Großhansdorf, Germany, 22927
- Pfizer Investigational Site
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Wiesbaden, Germany, 65187
- Pfizer Investigational Site
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Goteborg, Sweden, 413 45
- Pfizer Investigational Site
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Lund, Sweden, 221 85
- Pfizer Investigational Site
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Manchester, United Kingdom, M23 9QZ
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Peak and Trough (24 hour post dose) FEV1.
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Secondary Outcome Measures
Outcome Measure |
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Peak and trough (24 hour post dose) PEFR
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FEV1 and PEFR measurements to 32 hours post dose.
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Pharmacokinetics of PF-610,355 and salmeterol
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Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Study Registration Dates
First Submitted
May 2, 2007
First Submitted That Met QC Criteria
May 2, 2007
First Posted (Estimate)
May 3, 2007
Study Record Updates
Last Update Posted (Estimate)
November 1, 2010
Last Update Submitted That Met QC Criteria
October 27, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Salmeterol Xinafoate
Other Study ID Numbers
- A7881004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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