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

October 11, 2018 updated by: Pfizer

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).

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Pfizer Investigational Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1425DQI
        • Pfizer Investigational Site
      • Buenos Aires, Capital Federal, Argentina, C1426ABP
        • Pfizer Investigational Site
      • Ciudad Autonoma de Buenos Aires (CABA), Capital Federal, Argentina, C1428DDE
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Pfizer Investigational Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
      • Talca, Chile, 3460001
        • Pfizer Investigational Site
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7500691
        • Pfizer Investigational Site
    • V Región
      • Valparaiso, V Región, Chile, 2352499
        • Pfizer Investigational Site
      • Cvikov, Czechia, 471 54
        • Pfizer Investigational Site
      • Kutna Hora, Czechia, 283 01
        • Pfizer Investigational Site
      • Liberec, Czechia, 460 01
        • Pfizer Investigational Site
      • Praha 5, Czechia, 153 00
        • Pfizer Investigational Site
      • Strakonice, Czechia, 387 01
        • Pfizer Investigational Site
      • Tabor, Czechia, 39001
        • Pfizer Investigational Site
      • Lille, France, 59042 CEDEX
        • Pfizer Investigational Site
      • Marseille, France, 13009
        • Pfizer Investigational Site
      • Montpellier, France, 34295 CEDEX 5
        • Pfizer Investigational Site
      • Perpignan, France, 66000
        • Pfizer Investigational Site
      • Athens, Greece, 10676
        • Pfizer Investigational Site
      • Heraklion, Greece, 711 10
        • Pfizer Investigational Site
      • Larissa, Greece, 41 110
        • Pfizer Investigational Site
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1036
        • Pfizer Investigational Site
      • Deszk, Hungary, 6772
        • Pfizer Investigational Site
      • Pecs, Hungary, 7626
        • Pfizer Investigational Site
      • Szombathely, Hungary, 9700
        • Pfizer Investigational Site
      • Anyang, Korea, Republic of, 431-070
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Almere, Netherlands, 1311 RL
        • Pfizer Investigational Site
      • Zutphen, Netherlands, 7207 BA
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150023
        • Pfizer Investigational Site
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
      • Durban, South Africa, 4126
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Pfizer Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo
Experimental: PH-797804
PH-797804 at four dose levels
PH-797804 at four dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak expiratory flow rate.
Time Frame: 6 weeks
6 weeks
Blood sample for pharmacogenomics
Time Frame: 6 weeks
6 weeks
Blood sample for pharmacokinetics
Time Frame: 6 weeks
6 weeks
Rescue bronchodilator usage.
Time Frame: 6 weeks
6 weeks
Dyspnea index scores.
Time Frame: 6 weeks
6 weeks
Global impression of change (patient and clinician).
Time Frame: 6 weeks
6 weeks
Symptom scores.
Time Frame: 6 weeks
6 weeks
Blood sample for biomarkers
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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