Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01321463•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (74)

Pfizer Investigational Site

Mobile, Alabama, United States

Pfizer Investigational Site

Glendale, Arizona, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Clearwater, Florida, United States

Pfizer Investigational Site

Pensacola, Florida, United States

Pfizer Investigational Site

Tampa, Florida, United States

Pfizer Investigational Site

Tampa, Florida, United States

Pfizer Investigational Site

Trinity, Florida, United States

Pfizer Investigational Site

Conyers, Georgia, United States

Pfizer Investigational Site

Duluth, Georgia, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

July 11, 2013

Enrollment

377

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

PH-797804

DRUG

Placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

View study

RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The London COPD Exacerbation Cohort

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Air Filtration for COPD in VA Population of Veterans

A Study of the Effect of a Nurse Navigator Program on High Risk Patients

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)