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

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NCT00808288

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Study Location
Pfizer Investigational Site
Fairhope, Alabama, 36532, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive Lung Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive Lung DiseasesA Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT00808288
  1. Fairhope, Alabama
  2. San Diego, California
  3. Spring Valley, California
  4. Wheat Ridge, Colorado
  5. Daytona Beach, Florida
  6. Ormond Beach, Florida
  7. Tampa, Florida
  8. Trinity, Florida
  9. Austell, Georgia
  10. Overland Park, Kansas
  11. Overland Park, Kansas
  12. Fridley, Minnesota
  13. Minneapolis, Minnesota
  14. Rochester, Minnesota
  15. Saint Louis, Missouri
  16. Rochester, New York
  17. Charlotte, North Carolina
  18. Cincinnati, Ohio
  19. Cincinnati, Ohio
  20. Cincinnati, Ohio
  21. Cincinnati, Ohio
  22. Oklahoma City, Oklahoma
  23. Lincoln, Rhode Island
  24. Pawtucket, Rhode Island
  25. Charleston, South Carolina
  26. Charleston, South Carolina
  27. Columbia, South Carolina
  28. Houston, Texas
  29. San Antonio, Texas
  30. Morgantown, West Virginia
  31. Rosario, Santa Fe
  32. Buenos Aires,
  33. Buenos Aires,
  34. Ruse,
  35. Sofia,
  36. Sofia,
  37. Stara Zagora,
  38. Troyan,
  39. Zagreb,
  40. Kutna Hora,
  41. Liberec,
  42. Praha 5,
  43. Tabor,
  44. Berlin,
  45. Berlin,
  46. Frankfurt,
  47. Hamburg,
  48. Kassel,
  49. Luebeck,
  50. Schwerin,
  51. Wiesbaden,
  52. Budapest,
  53. Debrecen,
  54. Szeged,
  55. Szombathely,
  56. Torokbalint,
  57. Lodz,
  58. Sopot,
  59. Warszawa,
  60. Wejherowo,
  61. Bojnice,
  62. Bratislava,
  63. Liptovsky Hradok,
  64. Nove Zamky,
  65. Poprad,
  66. Spisska Nova Ves,
  67. Bellville, Cape Town
  68. Tygerberg, Cape Town
  69. Bloemfontein, Free State
  70. Bloemfontein,
  71. Gatesville, Cape Town,
  72. Salt, Girona
  73. Pozuelo de Alarcon, Madrid
  74. Istanbul,
  75. Izmir,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
Official Title  ICMJE 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.
Brief Summary To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Lung Diseases, Obstructive
Intervention  ICMJE
  • Drug: PF-00610355
    oral, inhaled, dry powder, 600ug, OD
  • Drug: PF - 00610355
    oral, inhaled, dry powder, 300ug, OD
  • Drug: PF- 00610355
    oral, inhaled, dry powder, 100ug, OD
  • Drug: Placebo
    oral, inhaled, dry powder, placebo, OD
  • Drug: Salmeterol
    salmeterol, 50ug, BID
Study Arms  ICMJE
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF- 00610355
    Intervention: Drug: PF - 00610355
  • Experimental: PF - 00610355
    Intervention: Drug: PF- 00610355
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Salmeterol
    Intervention: Drug: Salmeterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2011)		405
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)		380
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Croatia,   Czechia,   Germany,   Hungary,   Poland,   Slovakia,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00808288
Other Study ID Numbers  ICMJE A7881013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP