A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559910

Enrollment

230

Registered

2007-11-16

Start date

2008-02-29

Completion date

2009-12-31

Last updated

2018-10-16

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

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGPH-797804

PH-797804 at four dose levels

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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 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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.	6 weeks
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.	6 weeks

Secondary

Measure	Time frame
Blood sample for pharmacokinetics	6 weeks
Rescue bronchodilator usage.	6 weeks
Dyspnea index scores.	6 weeks
Peak expiratory flow rate.	6 weeks
Symptom scores.	6 weeks
Blood sample for biomarkers	6 weeks
Global impression of change (patient and clinician).	6 weeks
Blood sample for pharmacogenomics	6 weeks

Countries

Argentina, Australia, Canada, Chile, Czechia, France, Greece, Hungary, Netherlands, Russia, South Africa, South Korea, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026