A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics
NCT00150397
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- Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
- Reversibility to albuterol at least 12% and 200 mL
- Any significant co-morbid disease, particularly cardiovascular
- Use of any maintenance therapy except short acting bronchodilators
- Smoking history > or = 10 years
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics | |||
Official Title ICMJE | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma | |||
Brief Summary | This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma | |||
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 | Asthma | |||
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 | 112 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2005 | |||
Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 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 | Costa Rica, India, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00150397 | |||
Other Study ID Numbers ICMJE | A2641021 | |||
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 | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |