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


Tracking Information

Start Date  ICMJEJanuary 2008
Estimated Primary Completion DateJanuary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 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 ] [ Designated as safety issue: Yes ]
  • Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 15, 2007)
  • Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
  • Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
Change HistoryComplete list of historical versions of study NCT00559910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 9, 2008)
  • Peak expiratory flow rate. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacogenomics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Rescue bronchodilator usage. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Dyspnea index scores. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Global impression of change (patient and clinician). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Symptom scores. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Blood sample for biomarkers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.

Descriptive Information

Brief Title  ICMJEA 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  ICMJEA 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 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEChronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: PH-797804
    PH-797804 at four dose levels
  • Drug: Placebo
    Placebo
Study Arms / Comparison Groups
  • PH-797804: Experimental
    PH-797804 at four dose levels
    Intervention: Drug: PH-797804
  • Placebo: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE256
Estimated Completion DateJanuary 2010
Estimated Primary Completion DateJanuary 2010   (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.
GenderBoth
Ages40 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEArgentina,   Australia,   Canada,   Chile,   Czech Republic,   France,   Greece,   Hungary,   Korea, Republic of,   Netherlands,   Russian Federation,   South Africa,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00559910
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA6631011
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer