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

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NCT01321463

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, 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.
Pulmonary Disease, Chronic Obstructive
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

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


- 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.

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Pulmonary Disease, Chronic ObstructiveStudy 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
NCT01321463
  1. Mobile, Alabama
  2. Glendale, Arizona
  3. San Diego, California
  4. Clearwater, Florida
  5. Pensacola, Florida
  6. Tampa, Florida
  7. Tampa, Florida
  8. Trinity, Florida
  9. Conyers, Georgia
  10. Duluth, Georgia
  11. Norcross, Georgia
  12. Livonia, Michigan
  13. Fridley, Minnesota
  14. Minneapolis, Minnesota
  15. Rochester, Minnesota
  16. St. Louis, Missouri
  17. Cincinnati, Ohio
  18. Cincinnati, Ohio
  19. Lincoln, Rhode Island
  20. Spartanburg, South Carolina
  21. Houston, Texas
  22. Mckinney, Texas
  23. Capital Federal, Buenos Aires
  24. Rosario, Santa Fe
  25. Buenos Aires,
  26. Daw Park, South Australia
  27. Nedlands, Western Australia
  28. Ruse,
  29. Sevlievo,
  30. Sofia,
  31. Sofia,
  32. Stara Zagora,
  33. Calgary, Alberta
  34. Niagara Falls, Ontario
  35. Ottawa, Ontario
  36. Toronto, Ontario
  37. Trois-Rivieres, Quebec
  38. Quebec,
  39. Quillota, V Region
  40. Valparaiso, V Region
  41. Kutna Hora,
  42. Liberec,
  43. Pardubice,
  44. Praha 10- Malesice,
  45. Tabor,
  46. Budapest,
  47. Gyula,
  48. Szeged,
  49. Szombathely,
  50. Ahmedabad, Gujarat
  51. Nagpur, Maharashtra
  52. Coimbatore, Tamil Nadu
  53. Newtown,
  54. Tauranga,
  55. Leczna,
  56. Warszawa,
  57. Zawadzkie,
  58. Bojnice,
  59. Bratislava,
  60. Kosice,
  61. Liptovsky Hradok,
  62. Povazska Bystrica,
  63. Spisska Nova Ves,
  64. Bellville, Cape Town
  65. Tygerberg Campus, Cape Town
  66. Amanzimtoti, Durban
  67. Durban, Kwa-Zulu Natal
  68. Bloemfontein,
  69. Goteborg,
  70. Goteborg,
  71. Lund,
  72. Stockholm,
  73. Cottingham, Hull
  74. Glasgow,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: PH-797804
    6 mg oral tablet once daily for 12 weeks
  • Drug: Placebo
    Placebo oral tablet once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: PH-797804
    Intervention: Drug: PH-797804
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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: July 25, 2012)		377
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2011)		328
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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,   Australia,   Bulgaria,   Canada,   Chile,   Czech Republic,   Hungary,   India,   New Zealand,   Poland,   Slovakia,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321463
Other Study ID Numbers  ICMJE A6631029
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 July 2012

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