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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 : April 26, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: PH-797804 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : February 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PH-797804
PH-797804 at four dose levels
Drug: PH-797804
PH-797804 at four dose levels
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Peak expiratory flow rate. [ Time Frame: 6 weeks ]
  2. Blood sample for pharmacogenomics [ Time Frame: 6 weeks ]
  3. Blood sample for pharmacokinetics [ Time Frame: 6 weeks ]
  4. Rescue bronchodilator usage. [ Time Frame: 6 weeks ]
  5. Dyspnea index scores. [ Time Frame: 6 weeks ]
  6. Global impression of change (patient and clinician). [ Time Frame: 6 weeks ]
  7. Symptom scores. [ Time Frame: 6 weeks ]
  8. Blood sample for biomarkers [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559910


  Show 45 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00559910     History of Changes
Other Study ID Numbers: A6631011
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases