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

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00150397
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in FEV1 compared to placebo

Secondary Outcome Measures

Name	Time	Method
Change from baseline in other lung function parameters, disease control and quality of life compared to placebo

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Noida, Uttar Pradesh, India