CClinicalTrials.gg
CompletedNCT00808288A7881013Updated Feb 6, 2019

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

A Phase 2 interventional study of PF-00610355 and PF - 00610355 in Pulmonary Disease, Chronic Obstructive, Lung Diseases and Lung Diseases, Obstructive, sponsored by Pfizer. Completed at 75 sites in 12 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-06.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Lung Diseases, Obstructive

Keywords

  • COPD Respiratory Long acting beta agonist
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 405 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
405 participants (actual)

Study arms

  • Experimental
    PF-00610355

    Drug: PF-00610355

  • Experimental
    PF- 00610355

    Drug: PF - 00610355

  • Experimental
    PF - 00610355

    Drug: PF- 00610355

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Salmeterol

    Drug: Salmeterol

Interventions

  • DrugPF-00610355

    oral, inhaled, dry powder, 600ug, OD

  • DrugPF - 00610355

    oral, inhaled, dry powder, 300ug, OD

  • DrugPF- 00610355

    oral, inhaled, dry powder, 100ug, OD

  • DrugPlacebo

    oral, inhaled, dry powder, placebo, OD

  • DrugSalmeterol

    salmeterol, 50ug, BID

06

What researchers measure

Primary outcomes

  1. Change from baseline in trough FEV1

    Time frame: 6 week

Secondary outcomes

  1. Maximal and mean changes from baseline in heart rate, QTc and plasma potassium

    Time frame: each visit

  2. Change from baseline in peak FEV1

    Time frame: 0-6 hours /6 weeks

  3. Change from baseline in trough and peak FEV6, FVC and IC

    Time frame: 6 weeks

  4. Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)

    Time frame: 2 and 4 weeks

  5. Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)

    Time frame: 2,4,6 weeks

  6. Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).

    Time frame: weekly

07

Study locations

75 sites
  • Pfizer Investigational Site
    Fairhope, Alabama 36532, United States
  • Pfizer Investigational Site
    San Diego, California 92120, United States
  • Pfizer Investigational Site
    Spring Valley, California 91978, United States
  • Pfizer Investigational Site
    Wheat Ridge, Colorado 80033, United States
  • Pfizer Investigational Site
    Daytona Beach, Florida 32114, United States
  • Pfizer Investigational Site
    Ormond Beach, Florida 32174, United States
  • Pfizer Investigational Site
    Tampa, Florida 33613, United States
  • Pfizer Investigational Site
    Trinity, Florida 34655, United States
  • Pfizer Investigational Site
    Austell, Georgia 30106, United States
  • Pfizer Investigational Site
    Overland Park, Kansas 66211, United States
  • Pfizer Investigational Site
    Overland Park, Kansas 66212, United States
  • Pfizer Investigational Site
    Fridley, Minnesota 55432, United States
  • Pfizer Investigational Site
    Minneapolis, Minnesota 55407, United States
  • Pfizer Investigational Site
    Rochester, Minnesota 55905, United States
  • Pfizer Investigational Site
    Saint Louis, Missouri 63141, United States
  • Pfizer Investigational Site
    Rochester, New York 14618, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina 28207, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45227, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45231, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45242, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45245, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73112, United States
  • Pfizer Investigational Site
    Lincoln, Rhode Island 02865, United States
  • Pfizer Investigational Site
    Pawtucket, Rhode Island 02860, United States
  • Pfizer Investigational Site
    Charleston, South Carolina 29407, United States
  • Pfizer Investigational Site
    Charleston, South Carolina 29414, United States
  • Pfizer Investigational Site
    Columbia, South Carolina 29204, United States
  • Pfizer Investigational Site
    Houston, Texas 77030, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78212, United States
  • Pfizer Investigational Site
    Morgantown, West Virginia 26505, United States
  • Pfizer Investigational Site
    Rosario, Santa Fe 2000, Argentina
  • Pfizer Investigational Site
    Buenos Aires, 1426, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1405BCH, Argentina
  • Pfizer Investigational Site
    Ruse, 7002, Bulgaria
  • Pfizer Investigational Site
    Sofia, 1431, Bulgaria
  • Pfizer Investigational Site
    Sofia, 1606, Bulgaria
  • Pfizer Investigational Site
    Stara Zagora, 6003, Bulgaria
  • Pfizer Investigational Site
    Troyan, 5600, Bulgaria
  • Pfizer Investigational Site
    Zagreb, 10000, Croatia
  • Pfizer Investigational Site
    Kutna Hora, 283 01, Czechia
  • Pfizer Investigational Site
    Liberec, 460 01, Czechia
  • Pfizer Investigational Site
    Praha 5, 153 00, Czechia
  • Pfizer Investigational Site
    Tabor, 39001, Czechia
  • Pfizer Investigational Site
    Berlin, 12687, Germany
  • Pfizer Investigational Site
    Berlin, 14057, Germany
  • Pfizer Investigational Site
    Frankfurt, 60596, Germany
  • Pfizer Investigational Site
    Hamburg, 20354, Germany
  • Pfizer Investigational Site
    Kassel, 34121, Germany
  • Pfizer Investigational Site
    Luebeck, 23552, Germany
  • Pfizer Investigational Site
    Schwerin, 19055, Germany
  • Pfizer Investigational Site
    Wiesbaden, 65187, Germany
  • Pfizer Investigational Site
    Budapest, 1125, Hungary
  • Pfizer Investigational Site
    Debrecen, 4012, Hungary
  • Pfizer Investigational Site
    Szeged, 6772, Hungary
  • Pfizer Investigational Site
    Szombathely, 9700, Hungary
  • Pfizer Investigational Site
    Torokbalint, 2045, Hungary
  • Pfizer Investigational Site
    Lodz, 90-153, Poland
  • Pfizer Investigational Site
    Sopot, 81-741, Poland
  • Pfizer Investigational Site
    Warszawa, 04-141, Poland
  • Pfizer Investigational Site
    Wejherowo, 84-200, Poland
  • Pfizer Investigational Site
    Bojnice, 972 01, Slovakia
  • Pfizer Investigational Site
    Bratislava, 826 06, Slovakia
  • Pfizer Investigational Site
    Liptovsky Hradok, 033 01, Slovakia
  • Pfizer Investigational Site
    Nove Zamky, 940 01, Slovakia
  • Pfizer Investigational Site
    Poprad, 058 01, Slovakia
  • Pfizer Investigational Site
    Spisska Nova Ves, 052 01, Slovakia
  • Pfizer Investigational Site
    Bellville, Cape Town 7530, South Africa
  • Pfizer Investigational Site
    Tygerberg, Cape Town 7505, South Africa
  • Pfizer Investigational Site
    Bloemfontein, Free State 9301, South Africa
  • Pfizer Investigational Site
    Bloemfontein, South Africa
  • Pfizer Investigational Site
    Gatesville, Cape Town, 7764, South Africa
  • Pfizer Investigational Site
    Salt, Girona 17190, Spain
  • Pfizer Investigational Site
    Pozuelo de Alarcon, Madrid 28223, Spain
  • Pfizer Investigational Site
    Istanbul, 34098, Turkey
  • Pfizer Investigational Site
    Izmir, 35100, Turkey
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00808288
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 15, 2008
Start date
Mar 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Feb 6, 2019

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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