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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Barrio Aranjuez, Provincia de San José, Costa Rica

Who can participate

Healthy volunteers accepted: No

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

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

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, disease control and quality of life compared to placebo

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Sep 8, 2005
Registry last updated: Jun 8, 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