Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

NCT ID: NCT00430300

Last Updated: 2013-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

Brief Summary

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Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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150mcg, 450mcg or 1350mcg

Active treatment given BID via a double pin monodose capsule inhaler device

Group Type EXPERIMENTAL

UK-432,097

Intervention Type DRUG

Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.

Placebo

Placebo treatment given BID via a single pin monodose inhaler device

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules containing 100% lactose administered BID using an atomizer device

Interventions

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UK-432,097

Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.

Intervention Type DRUG

Placebo

Capsules containing 100% lactose administered BID using an atomizer device

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
* Patients must have a smoking history of at least 10 pack-years
* Patients must have stable disease for at least 1 month prior to screening.

Exclusion Criteria

* More than 2 exacerbations of COPD in the preceding year
* History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
* History or presence of respiratory failure, cor pulmonale or right ventricular failure
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Camperdown, New South Wales, Australia

Site Status

Pfizer Investigational Site

Glebe, New South Wales, Australia

Site Status

Pfizer Investigational Site

Daw Park, South Australia, Australia

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Pfizer Investigational Site

Nedlands, Western Australia, Australia

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Pfizer Investigational Site

Calgary, Alberta, Canada

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Pfizer Investigational Site

Red Deer, Alberta, Canada

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Pfizer Investigational Site

Hamilton, Ontario, Canada

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Pfizer Investigational Site

Québec, Quebec, Canada

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Pfizer Investigational Site

Trois-Rivières, Quebec, Canada

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Pfizer Investigational Site

Almelo, , Netherlands

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Pfizer Investigational Site

Eindhoven, , Netherlands

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Pfizer Investigational Site

Zuthpen, , Netherlands

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Pfizer Investigational Site

Bydgoszcz, Poland, Poland

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Pfizer Investigational Site

Gdansk, Poland, Poland

Site Status

Pfizer Investigational Site

Warsaw, Poland, Poland

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Pfizer Investigational Site

Lodz, , Poland

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Pfizer Investigational Site

Chertsey, Surrey, United Kingdom

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Pfizer Investigational Site

Leicester, , United Kingdom

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Pfizer Investigational Site

London, , United Kingdom

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Pfizer Investigational Site

Manchester, , United Kingdom

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Pfizer Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

Pfizer Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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Australia Canada Netherlands Poland United Kingdom

Related Links

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Other Identifiers

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A3971013

Identifier Type: -

Identifier Source: org_study_id

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