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

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).

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263874

Enrollment

324

Registered

2005-12-09

Start date

2005-11-30

Completion date

2006-09-30

Last updated

2007-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DRUGUK-500,001

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo	—

Secondary

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

Countries

Argentina, Australia, Canada, Chile, Croatia, Czechia, Hungary, Singapore, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026