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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Tofimilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150397

A2641021

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind