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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).

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00559910
First received: November 15, 2007
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: PH-797804
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 230
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559910

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00559910     History of Changes
Other Study ID Numbers: A6631011
Study First Received: November 15, 2007
Last Updated: April 22, 2011
Health Authority: UK: MREC

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

ClinicalTrials.gov processed this record on May 16, 2013