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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01321463
First received: March 21, 2011
Last updated: July 8, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
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, Caregiver, Investigator, Outcomes Assessor)
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 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Symptom scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PH-797804 Drug: PH-797804
6 mg oral tablet once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo oral tablet once daily for 12 weeks

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321463

  Show 74 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01321463     History of Changes
Other Study ID Numbers: A6631029
Study First Received: March 21, 2011
Last Updated: July 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 31, 2014