Skip to main content
OpenTrials
Completed

NCT Number: NCT00559910

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, La Plata, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PH-797804

Drug

PH-797804 at four dose levels

Placebo

Drug

Placebo

Primary outcomes

  1. 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

  2. Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.

    Time frame: 6 weeks

Secondary outcomes

  1. Peak expiratory flow rate.

    Time frame: 6 weeks

  2. Blood sample for pharmacogenomics

    Time frame: 6 weeks

  3. Blood sample for pharmacokinetics

    Time frame: 6 weeks

  4. Rescue bronchodilator usage.

    Time frame: 6 weeks

  5. Dyspnea index scores.

    Time frame: 6 weeks

  6. Global impression of change (patient and clinician).

    Time frame: 6 weeks

  7. Symptom scores.

    Time frame: 6 weeks

  8. Blood sample for biomarkers

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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).

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2007
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.