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Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

NCT ID: NCT01321463

Last Updated: 2013-07-11

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

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

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PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PH-797804

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

6 mg oral tablet once daily for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablet once daily for 12 weeks

Interventions

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PH-797804

6 mg oral tablet once daily for 12 weeks

Intervention Type DRUG

Placebo

Placebo oral tablet once daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects between, and including, the ages of 40 and 80 years.
* Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
* Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago.
* Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.

Exclusion Criteria

* A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
* History or presence of significant cardiovascular disease.
* ECG abnormalities.
* Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
* Evidence of organ or blood disorders.
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

Mobile, Alabama, United States

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Glendale, Arizona, United States

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San Diego, California, United States

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Clearwater, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Trinity, Florida, United States

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Conyers, Georgia, United States

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Duluth, Georgia, United States

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Norcross, Georgia, United States

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Livonia, Michigan, 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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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Lincoln, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Capital Federal, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Daw Park, South Australia, Australia

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Nedlands, Western Australia, Australia

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Rousse, , Bulgaria

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Sevlievo, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Calgary, Alberta, Canada

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Niagara Falls, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Quillota, Región de Valparaíso, Chile

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Valparaíso, Región de Valparaíso, Chile

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Kutná Hora, , Czechia

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Liberec, , Czechia

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Pardubice, , Czechia

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Praha 10- Malesice, , Czechia

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Tábor, , Czechia

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Budapest, , Hungary

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Gyula, , Hungary

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Szeged, , Hungary

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Szombathely, , Hungary

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Ahmedabad, Gujarat, India

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Nagpur, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Newtown, , New Zealand

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Tauranga, , New Zealand

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Warsaw, , Poland

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Zawadzkie, , Poland

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Łęczna, , Poland

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Považská Bystrica, , Slovakia

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Spišská Nová Ves, , Slovakia

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Bellville, Cape Town, South Africa

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Tygerberg Campus, Cape Town, South Africa

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eManzimtoti, Durban, South Africa

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Durban, KwaZulu-Natal, South Africa

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Bloemfontein, , South Africa

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Cottingham, Hull, United Kingdom

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Glasgow, , United Kingdom

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Countries

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United States Argentina Australia Bulgaria Canada Chile Czechia Hungary India New Zealand Poland Slovakia South Africa Sweden United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631029&StudyName=Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20PH-797804%20For%2012%20Weeks%20In%20Adults%20With%20Moderate%20To%20Severe%20Chronic%20Obstructive%20Pulmonary%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6631029

Identifier Type: -

Identifier Source: org_study_id

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