Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD - Full Text View

Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

This study has been terminated.
( The decision to terminate was completely related to efficacy and there were no safety concerns. )

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00263874

Purpose

This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: UK-500,001	Phase II

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Secondary Outcome Measures:

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

Estimated Enrollment:	324
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
Smoking history of at least 10 pack-years

Exclusion Criteria:

Any significant co-morbid disease
Use of any maintenance therapy except short acting bronchodilators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263874

Show 28 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A5641009
First Received:	December 8, 2005
Last Updated:	July 20, 2007
ClinicalTrials.gov Identifier:	NCT00263874
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Chronic Disease

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes

Pathologic Processes

ClinicalTrials.gov processed this record on October 27, 2008