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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, La Plata, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tofimilast

Drug

Primary outcomes

Change from baseline in FEV1 compared to placebo

Secondary outcomes

Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 22, 2005
Registry last updated: Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed