A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
NCT00219622
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- Moderate-severe COPD (GOLD 2003 definition)
- Smoking history of at least 10 pack-years
- Any significant co-morbid disease, particularly cardiovascular
- Use of any maintenance therapy except short acting bronchodilators
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease | |||
Official Title ICMJE | Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease | |||
Brief Summary | This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Disease, Chronic Obstructive | |||
Intervention ICMJE | Drug: tofimilast | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 300 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2005 | |||
Actual Primary Completion Date | July 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 40 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Brazil, Chile, Costa Rica, Mexico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00219622 | |||
Other Study ID Numbers ICMJE | A2641022 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |