A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT ID: NCT00808288

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, 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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PF-00610355

Group Type EXPERIMENTAL

PF-00610355

Intervention Type DRUG

oral, inhaled, dry powder, 600ug, OD

PF- 00610355

Group Type EXPERIMENTAL

PF - 00610355

Intervention Type DRUG

oral, inhaled, dry powder, 300ug, OD

PF - 00610355

Group Type EXPERIMENTAL

PF- 00610355

Intervention Type DRUG

oral, inhaled, dry powder, 100ug, OD

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral, inhaled, dry powder, placebo, OD

Salmeterol

Group Type ACTIVE_COMPARATOR

Salmeterol

Intervention Type DRUG

salmeterol, 50ug, BID

Interventions

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PF-00610355

oral, inhaled, dry powder, 600ug, OD

Intervention Type DRUG

PF - 00610355

oral, inhaled, dry powder, 300ug, OD

Intervention Type DRUG

PF- 00610355

oral, inhaled, dry powder, 100ug, OD

Intervention Type DRUG

Placebo

oral, inhaled, dry powder, placebo, OD

Intervention Type DRUG

Salmeterol

salmeterol, 50ug, BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%.
* Diagnosis of moderate COPD for a minimum of 6 months.
* Stable disease for at least 1 month prior to screening

Exclusion Criteria

* More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
* History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
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

Fairhope, Alabama, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Wheat Ridge, Colorado, United States

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Daytona Beach, Florida, United States

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Ormond Beach, Florida, United States

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Tampa, Florida, United States

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Trinity, Florida, United States

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Austell, Georgia, United States

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Overland Park, Kansas, United States

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Overland Park, Kansas, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lincoln, Rhode Island, United States

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Pawtucket, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Morgantown, West Virginia, United States

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Troyan Municipality, , Bulgaria

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Zagreb, , Croatia

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Kutná Hora, , Czechia

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Liberec, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Kassel, , Germany

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Lübeck, , Germany

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Schwerin, , Germany

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Wiesbaden, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Szeged, , Hungary

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Szombathely, , Hungary

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Törökbálint, , Hungary

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Lodz, , Poland

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Sopot, , Poland

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Warsaw, , Poland

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Wejherowo, , Poland

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Liptovský Hrádok, , Slovakia

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Nové Zámky, , Slovakia

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Poprad, , Slovakia

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Spišská Nová Ves, , Slovakia

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Bellville, Cape Town, South Africa

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Tygerberg, Cape Town, South Africa

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Bloemfontein, Free State, South Africa

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Bloemfontein, , South Africa

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Gatesville, Cape Town, , South Africa

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Salt, Girona, Spain

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Pozuelo de Alarcón, Madrid, Spain

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Bulgaria Croatia Czechia Germany Hungary Poland Slovakia South Africa Spain Turkey (Türkiye)

Related Links

Other Identifiers

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A7881013

Identifier Type: -

Identifier Source: org_study_id

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