Clinical trial NCT00263874: Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 324
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary outcomes:
measure: Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa FÃ©
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: ValparaÃ-so
country: Chile
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava-Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Tabor
country: Czech Republic
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Torokbalint
country: Hungary
facility: Pfizer Investigational Site
city: Veszprem
country: Hungary
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Vestbo J, Tan L, Atkinson G, Ward J; UK-500,001 Global Study Team. A controlled trial of 6-weeks' treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur Respir J. 2009 May;33(5):1039-44. doi: 10.1183/09031936.00068908. Epub 2009 Feb 12.