Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PH-797804

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PH-797804

Placebo

Arm Description

PH-797804 at four dose levels

Placebo

Outcomes

Primary Outcome Measures

Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.

Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.

Secondary Outcome Measures

Peak expiratory flow rate.

Blood sample for pharmacogenomics

Blood sample for pharmacokinetics

Rescue bronchodilator usage.

Dyspnea index scores.

Global impression of change (patient and clinician).

Symptom scores.

Blood sample for biomarkers

Full Information

NCT ID

NCT00559910

First Posted

November 15, 2007

Last Updated

October 11, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00559910

Brief Title

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

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PH-797804

Arm Type

Experimental

Arm Description

PH-797804 at four dose levels

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

PH-797804

Intervention Description

PH-797804 at four dose levels

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.

Time Frame

6 weeks

Title

Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Peak expiratory flow rate.

Time Frame

6 weeks

Title

Blood sample for pharmacogenomics

Time Frame

6 weeks

Title

Blood sample for pharmacokinetics

Time Frame

6 weeks

Title

Rescue bronchodilator usage.

Time Frame

6 weeks

Title

Dyspnea index scores.

Time Frame

6 weeks

Title

Global impression of change (patient and clinician).

Time Frame

6 weeks

Title

Symptom scores.

Time Frame

6 weeks

Title

Blood sample for biomarkers

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

C1425DQI

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Ciudad Autonoma de Buenos Aires (CABA)

State/Province

Capital Federal

ZIP/Postal Code

C1428DDE

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Pfizer Investigational Site

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

Pfizer Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2K 3S8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Providencia

State/Province

Santiago, RM

ZIP/Postal Code

7500691

Country

Chile

Facility Name

Pfizer Investigational Site

City

Valparaiso

State/Province

V Región

ZIP/Postal Code

2352499

Country

Chile

Facility Name

Pfizer Investigational Site

City

Talca

ZIP/Postal Code

3460001

Country

Chile

Facility Name

Pfizer Investigational Site

City

Cvikov

ZIP/Postal Code

471 54

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Kutna Hora

ZIP/Postal Code

283 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Liberec

ZIP/Postal Code

460 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Praha 5

ZIP/Postal Code

153 00

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Strakonice

ZIP/Postal Code

387 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Tabor

ZIP/Postal Code

39001

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59042 CEDEX

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34295 CEDEX 5

Country

France

Facility Name

Pfizer Investigational Site

City

Perpignan

ZIP/Postal Code

66000

Country

France

Facility Name

Pfizer Investigational Site

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

Pfizer Investigational Site

City

Heraklion

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Pfizer Investigational Site

City

Larissa

ZIP/Postal Code

41 110

Country

Greece

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

H-1036

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Pecs

ZIP/Postal Code

7626

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Anyang

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Almere

ZIP/Postal Code

1311 RL

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Zutphen

ZIP/Postal Code

7207 BA

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Yaroslavl

ZIP/Postal Code

150023

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Durban

State/Province

Kwa-Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Durban

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23539534

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial