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A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

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ClinicalTrials.gov Identifier: NCT00559910
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : October 16, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 15, 2007
First Posted Date  ICMJE November 16, 2007
Last Update Posted Date October 16, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]
  • Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
  • Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
  • Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
  • Peak expiratory flow rate. [ Time Frame: 6 weeks ]
  • Blood sample for pharmacogenomics [ Time Frame: 6 weeks ]
  • Blood sample for pharmacokinetics [ Time Frame: 6 weeks ]
  • Rescue bronchodilator usage. [ Time Frame: 6 weeks ]
  • Dyspnea index scores. [ Time Frame: 6 weeks ]
  • Global impression of change (patient and clinician). [ Time Frame: 6 weeks ]
  • Symptom scores. [ Time Frame: 6 weeks ]
  • Blood sample for biomarkers [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
  • Rescue bronchodilator usage.
  • Dyspnea index scores.
  • Global impression of change (patient and clinician).
  • Symptom scores.
  • Peak expiratory flow rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
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 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary PH-797804 is a potent 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: PH-797804
    PH-797804 at four dose levels
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PH-797804
    PH-797804 at four dose levels
    Intervention: Drug: PH-797804
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

*   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: March 3, 2010)
230
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2007)
256
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (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 had stable disease for at least 1 month prior to screening.
  • 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.

Exclusion Criteria:

  • More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
  • 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,   Canada,   Chile,   Czechia,   France,   Greece,   Hungary,   Korea, Republic of,   Netherlands,   Russian Federation,   South Africa,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00559910
Other Study ID Numbers  ICMJE A6631011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

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