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
Completed · Phase 2 · Has a placebo group
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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.
Key facts
- Study ID
- NCT01321463
- Run by
- Pfizer
- People needed
- 377
- Starts
- 2011-05-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-07-11
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- Pfizer Investigational Site — Norcross, Georgia, United States
- Pfizer Investigational Site — Livonia, Michigan, United States
- Pfizer Investigational Site — Fridley, Minnesota, United States
- Pfizer Investigational Site — Minneapolis, Minnesota, United States
- Pfizer Investigational Site — Rochester, Minnesota, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — Cincinnati, Ohio, United States
- Pfizer Investigational Site — Cincinnati, Ohio, United States
- Pfizer Investigational Site — Lincoln, Rhode Island, United States
- Pfizer Investigational Site — Spartanburg, South Carolina, United States
- Pfizer Investigational Site — Houston, Texas, United States
- Pfizer Investigational Site — McKinney, Texas, United States
- Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina
- Pfizer Investigational Site — Rosario, Santa Fe Province, Argentina
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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