CClinicalTrials.gg
TerminatedNCT00263874Updated Jul 23, 2007

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

A Phase 2 interventional study of UK-500,001 in Pulmonary Disease, Chronic Obstructive, sponsored by Pfizer. Terminated at 28 sites in 10 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-07-23.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Why this study was terminated
The decision to terminate was completely related to efficacy and there were no safety concerns.
Phase
Phase 2
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 324 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Any significant co-morbid disease
  • Use of any maintenance therapy except short acting bronchodilators
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
324 participants

Interventions

  • DrugUK-500,001
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

28 sites
  • Pfizer Investigational Site
    La Plata, Buenos Aires C1904AGP, Argentina
  • Pfizer Investigational Site
    Vicente Lopez, Buenos Aires 1602, Argentina
  • Pfizer Investigational Site
    Rosario, Santa Fé 2000, Argentina
  • Pfizer Investigational Site
    Buenos Aires, 1426, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1425DQU, Argentina
  • Pfizer Investigational Site
    Camperdown, New South Wales 2050, Australia
  • Pfizer Investigational Site
    Clayton, Victoria 3168a, Australia
  • Pfizer Investigational Site
    Nedlands, Western Australia 6009, Australia
  • Pfizer Investigational Site
    Calgary, Alberta T1Y 6J4, Canada
  • Pfizer Investigational Site
    Red Deer, Alberta T4N 6V7, Canada
  • Pfizer Investigational Site
    Hamilton, Ontario L8N 3Z5, Canada
  • Pfizer Investigational Site
    Kingston, Ontario K7L 2V7, Canada
  • Pfizer Investigational Site
    Santiago, RM 7500691, Chile
  • Pfizer Investigational Site
    Providencia, Santiago 7500691, Chile
  • Pfizer Investigational Site
    ValparaÃ-so, 2381594, Chile
  • Pfizer Investigational Site
    Zagreb, 10000, Croatia
  • Pfizer Investigational Site
    Olomouc, 775 20, Czech Republic
  • Pfizer Investigational Site
    Ostrava-Poruba, 708 52, Czech Republic
  • Pfizer Investigational Site
    Praha 5, 150 06, Czech Republic
  • Pfizer Investigational Site
    Tabor, 390 03, Czech Republic
  • Pfizer Investigational Site
    Debrecen, 4004, Hungary
  • Pfizer Investigational Site
    Torokbalint, 2045, Hungary
  • Pfizer Investigational Site
    Veszprem, 8200, Hungary
  • Pfizer Investigational Site
    Singapore, 308433, Singapore
  • Pfizer Investigational Site
    Singapore, 529889, Singapore
  • Pfizer Investigational Site
    Madrid, 28007, Spain
  • Pfizer Investigational Site
    Madrid, 28046, Spain
  • Pfizer Investigational Site
    Manchester, M23 9LT, United Kingdom
08

References and documents

Publications

  • 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. PubMed 19213793 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00263874
Lead sponsor
Pfizer
First posted
Dec 9, 2005
Start date
Nov 2005
Completion
Sep 2006
Last update
Jul 23, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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