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A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00150397
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date June 8, 2012
Study Start Date  ICMJE March 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Change from baseline in FEV1 compared to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00150397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Change from baseline in other lung function parameters, disease control and quality of life compared to placebo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
 (submitted: September 6, 2005)
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:

  • Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
  • Reversibility to albuterol at least 12% and 200 mL

Exclusion Criteria:

  • Any significant co-morbid disease, particularly cardiovascular
  • Use of any maintenance therapy except short acting bronchodilators
  • Smoking history > or = 10 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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