A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
This study has been completed.
Sponsor:
Pfizer
ClinicalTrials.gov Identifier:
NCT00468975
First Posted: May 3, 2007
Last Update Posted: November 1, 2010
Information provided by:
Pfizer
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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
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| 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 |