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A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT00559910

Last Updated: 2018-10-16

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

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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PH-797804 is a potent 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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Chronic Obstructive Pulmonary Disease

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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PH-797804

PH-797804 at four dose levels

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

PH-797804 at four dose levels

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PH-797804

PH-797804 at four dose levels

Intervention Type DRUG

Placebo

Placebo

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 had stable disease for at least 1 month prior to screening.
* 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.

Exclusion Criteria

* More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
* 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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Pfizer Investigational Site

Ciudad Autonoma de Buenos Aires (caba), Buenos Aires F.D., Argentina

Site Status

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

Pfizer Investigational Site

Camperdown, New South Wales, Australia

Site Status

Pfizer Investigational Site

Daw Park, South Australia, Australia

Site Status

Pfizer Investigational Site

Nedlands, Western Australia, Australia

Site Status

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

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Pfizer Investigational Site

Hamilton, Ontario, Canada

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Pfizer Investigational Site

Kingston, Ontario, Canada

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Pfizer Investigational Site

Sainte-Foy, Quebec, Canada

Site Status

Pfizer Investigational Site

Valparaíso, Región de Valparaíso, Chile

Site Status

Pfizer Investigational Site

Providencia, Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Talca, , Chile

Site Status

Pfizer Investigational Site

Cvikov, , Czechia

Site Status

Pfizer Investigational Site

Kutná Hora, , Czechia

Site Status

Pfizer Investigational Site

Liberec, , Czechia

Site Status

Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Strakonice, , Czechia

Site Status

Pfizer Investigational Site

Tábor, , Czechia

Site Status

Pfizer Investigational Site

Lille, , France

Site Status

Pfizer Investigational Site

Marseille, , France

Site Status

Pfizer Investigational Site

Montpellier, , France

Site Status

Pfizer Investigational Site

Perpignan, , France

Site Status

Pfizer Investigational Site

Athens, , Greece

Site Status

Pfizer Investigational Site

Heraklion, , Greece

Site Status

Pfizer Investigational Site

Larissa, , Greece

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Deszk, , Hungary

Site Status

Pfizer Investigational Site

Pécs, , Hungary

Site Status

Pfizer Investigational Site

Szombathely, , Hungary

Site Status

Pfizer Investigational Site

Almere Stad, , Netherlands

Site Status

Pfizer Investigational Site

Zutphen, , Netherlands

Site Status

Pfizer Investigational Site

Yaroslavl, , Russia

Site Status

Pfizer Investigational Site

Yaroslavl, , Russia

Site Status

Pfizer Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Pfizer Investigational Site

Bloemfontein, , South Africa

Site Status

Pfizer Investigational Site

Durban, , South Africa

Site Status

Pfizer Investigational Site

Anyang, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Countries

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Argentina Australia Canada Chile Czechia France Greece Hungary Netherlands Russia South Africa South Korea United Kingdom

References

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MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

Reference Type DERIVED
PMID: 23539534 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631011

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

Other Identifiers

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A6631011

Identifier Type: -

Identifier Source: org_study_id

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