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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01321463
First received: March 21, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes

March 21, 2011
July 25, 2012
May 2011
June 2012   (final data collection date for primary outcome measure)
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321463 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Symptom scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Symptom scores [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: PH-797804
    6 mg oral tablet once daily for 12 weeks
  • Drug: Placebo
    Placebo oral tablet once daily for 12 weeks
  • Experimental: PH-797804
    Intervention: Drug: PH-797804
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
377
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Czech Republic,   Hungary,   India,   New Zealand,   Poland,   Slovakia,   South Africa,   Sweden,   United Kingdom
 
NCT01321463
A6631029
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

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