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

July 8, 2013 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 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

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

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1440BRR
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Pfizer Investigational Site
  • Australia
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Pfizer Investigational Site
      • Sevlievo, Bulgaria, 5400
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1431
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1407
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6003
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Pfizer Investigational Site
    • Ontario
      • Niagara Falls, Ontario, Canada, L2G 1J4
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6H 3M2
        • Pfizer Investigational Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8T 7A1
        • Pfizer Investigational Site
  • Chile
    • V Region
      • Quillota, V Region, Chile, 2260494
        • Pfizer Investigational Site
      • Valparaiso, V Region, Chile, 2352499
        • Pfizer Investigational Site
  • Czech Republic
      • Kutna Hora, Czech Republic, 284 01
        • Pfizer Investigational Site
      • Liberec, Czech Republic, 460 01
        • Pfizer Investigational Site
      • Pardubice, Czech Republic, 530 09
        • Pfizer Investigational Site
      • Praha 10- Malesice, Czech Republic, 108 00
        • Pfizer Investigational Site
      • Tabor, Czech Republic, 39001
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Gyula, Hungary, 5703
        • Pfizer Investigational Site
      • Szeged, Hungary, 6722
        • Pfizer Investigational Site
      • Szombathely, Hungary, 9700
        • Pfizer Investigational Site
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 052
        • Pfizer Investigational Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440 012
        • Pfizer Investigational Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 004
        • Pfizer Investigational Site
  • New Zealand
      • Newtown, New Zealand, 6021
        • Pfizer Investigational Site
      • Tauranga, New Zealand, 3110
        • Pfizer Investigational Site
  • Poland
      • Leczna, Poland, 21-010
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-141
        • Pfizer Investigational Site
      • Zawadzkie, Poland, 47-120
        • Pfizer Investigational Site
  • Slovakia
      • Bojnice, Slovakia, 972 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 01
        • Pfizer Investigational Site
      • Liptovsky Hradok, Slovakia, 033 01
        • Pfizer Investigational Site
      • Povazska Bystrica, Slovakia, 017 26
        • Pfizer Investigational Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
    • Cape Town
      • Bellville, Cape Town, South Africa, 7530
        • Pfizer Investigational Site
      • Tygerberg Campus, Cape Town, South Africa, 7505
        • Pfizer Investigational Site
    • Durban
      • Amanzimtoti, Durban, South Africa, 4126
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Goteborg, Sweden, 400 14
        • Pfizer Investigational Site
      • Lund, Sweden, 22185
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 OYN
        • Pfizer Investigational Site
    • Hull
      • Cottingham, Hull, United Kingdom, HU16 5JQ
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32504
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33603
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Trinity, Florida, United States, 34655
        • Pfizer Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Pfizer Investigational Site
      • Duluth, Georgia, United States, 30096
        • Pfizer Investigational Site
      • Norcross, Georgia, United States, 30071
        • Pfizer Investigational Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Pfizer Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55407
        • Pfizer Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Mckinney, Texas, United States, 75069
        • 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 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.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo oral tablet once daily for 12 weeks
Experimental: PH-797804
Drug: PH-797804
6 mg oral tablet once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
Time Frame: 12 Weeks
12 Weeks
Dyspnea index scores.
Time Frame: 12 Weeks
12 Weeks
Rescue bronchodilator usage.
Time Frame: 12 Weeks
12 Weeks
Symptom scores.
Time Frame: 12 Weeks
12 Weeks
Global impression of change (patient and clinician).
Time Frame: 12 Weeks
12 Weeks
Blood sample for pharmacokinetics.
Time Frame: 12 Weeks
12 Weeks
Blood and urine sample for biomarkers and molecular profiling.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

May 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6631029

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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