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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

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ClinicalTrials.gov Identifier: NCT01321463
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 21, 2011
First Posted Date  ICMJE March 23, 2011
Last Update Posted Date July 11, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01321463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • 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 ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ]
  • Symptom scores. [ Time Frame: 12 Weeks ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
  • 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 ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ]
  • Symptom scores [ Time Frame: 12 Weeks ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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