A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. (A7881013)

February 1, 2019 updated by: Pfizer

A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

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, Argentina, C1405BCH
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Pfizer Investigational Site
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1431
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1606
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6003
        • Pfizer Investigational Site
      • Troyan, Bulgaria, 5600
        • Pfizer Investigational Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
  • Czechia
      • Kutna Hora, Czechia, 283 01
        • Pfizer Investigational Site
      • Liberec, Czechia, 460 01
        • Pfizer Investigational Site
      • Praha 5, Czechia, 153 00
        • Pfizer Investigational Site
      • Tabor, Czechia, 39001
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 12687
        • Pfizer Investigational Site
      • Berlin, Germany, 14057
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60596
        • Pfizer Investigational Site
      • Hamburg, Germany, 20354
        • Pfizer Investigational Site
      • Kassel, Germany, 34121
        • Pfizer Investigational Site
      • Luebeck, Germany, 23552
        • Pfizer Investigational Site
      • Schwerin, Germany, 19055
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65187
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4012
        • Pfizer Investigational Site
      • Szeged, Hungary, 6772
        • Pfizer Investigational Site
      • Szombathely, Hungary, 9700
        • Pfizer Investigational Site
      • Torokbalint, Hungary, 2045
        • Pfizer Investigational Site
  • Poland
      • Lodz, Poland, 90-153
        • Pfizer Investigational Site
      • Sopot, Poland, 81-741
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-141
        • Pfizer Investigational Site
      • Wejherowo, Poland, 84-200
        • Pfizer Investigational Site
  • Slovakia
      • Bojnice, Slovakia, 972 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Liptovsky Hradok, Slovakia, 033 01
        • Pfizer Investigational Site
      • Nove Zamky, Slovakia, 940 01
        • Pfizer Investigational Site
      • Poprad, Slovakia, 058 01
        • Pfizer Investigational Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • Pfizer Investigational Site
      • Gatesville, Cape Town, South Africa, 7764
        • Pfizer Investigational Site
    • Cape Town
      • Bellville, Cape Town, South Africa, 7530
        • Pfizer Investigational Site
      • Tygerberg, Cape Town, South Africa, 7505
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Pfizer Investigational Site
  • Spain
    • Girona
      • Salt, Girona, Spain, 17190
        • Pfizer Investigational Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Pfizer Investigational Site
  • Turkey
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • Spring Valley, California, United States, 91978
        • Pfizer Investigational Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Trinity, Florida, United States, 34655
        • Pfizer Investigational Site
    • Georgia
      • Austell, Georgia, United States, 30106
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66212
        • 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
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29407
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29204
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78212
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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:

  • Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
  • Diagnosis of moderate COPD for a minimum of 6 months.
  • Stable disease for at least 1 month prior to screening

Exclusion Criteria:

  • More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
  • History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral, inhaled, dry powder, placebo, OD
Active Comparator: Salmeterol
Drug: Salmeterol
salmeterol, 50ug, BID
Experimental: PF- 00610355
Drug: PF - 00610355
oral, inhaled, dry powder, 300ug, OD
Experimental: PF-00610355
Drug: PF-00610355
oral, inhaled, dry powder, 600ug, OD
Experimental: PF - 00610355
Drug: PF- 00610355
oral, inhaled, dry powder, 100ug, OD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough FEV1
Time Frame: 6 week
6 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
Time Frame: each visit
each visit
Change from baseline in peak FEV1
Time Frame: 0-6 hours /6 weeks
0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC
Time Frame: 6 weeks
6 weeks
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
Time Frame: 2 and 4 weeks
2 and 4 weeks
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
Time Frame: 2,4,6 weeks
2,4,6 weeks
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).
Time Frame: weekly
weekly

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

March 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7881013

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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