A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219622

Enrollment

300

Registered

2005-09-22

Start date

2004-05-31

Completion date

2005-07-31

Last updated

2012-11-07

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

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease

Interventions

DRUGtofimilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Moderate-severe COPD (GOLD 2003 definition) * Smoking history of at least 10 pack-years

Exclusion criteria

* Any significant co-morbid disease, particularly cardiovascular * Use of any maintenance therapy except short acting bronchodilators

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, dyspnea, quality of life compared to placebo	—

Countries

Argentina, Brazil, Chile, Costa Rica, Mexico, United States

Outcome results

None listed

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