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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150397

Enrollment

112

Registered

2005-09-08

Start date

2005-03-31

Completion date

2005-11-30

Last updated

2012-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

DRUGTofimilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in FEV1 compared to placebo	—

Secondary

Measure	Time frame
Change from baseline in other lung function parameters, disease control and quality of life compared to placebo	—

Countries

Costa Rica, India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026