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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01321463

Enrollment

377

Registered

2011-03-23

Start date

2011-05-31

Completion date

2012-06-30

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief 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.

Interventions

DRUGPH-797804

6 mg oral tablet once daily for 12 weeks

DRUGPlacebo

Placebo oral tablet once daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.	12 Weeks

Secondary

Measure	Time frame
Dyspnea index scores.	12 Weeks
Rescue bronchodilator usage.	12 Weeks
Symptom scores.	12 Weeks
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.	12 Weeks
Blood sample for pharmacokinetics.	12 Weeks
Blood and urine sample for biomarkers and molecular profiling.	12 Weeks
Global impression of change (patient and clinician).	12 Weeks

Countries

Argentina, Australia, Bulgaria, Canada, Chile, Czechia, Hungary, India, New Zealand, Poland, Slovakia, South Africa, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026