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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01321463Tipo: INTERVENTIONALInicio: 1 de may de 2011Fin estimado: 1 de jun de 2012

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

PH-797804

6 mg oral tablet once daily for 12 weeks

drug

Placebo

Placebo oral tablet once daily for 12 weeks

Ubicaciones

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase II, Randomized, Double-Blind, Placebo-Controlled,... | EligiMed