A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease

CompletadoFase 2ClinicalTrials.gov

ID: NCT01218126Tipo: INTERVENTIONALInicio: 4 de nov de 2010Fin estimado: 21 de dic de 2011

Traducción no disponible, mostrando original

Resumen

Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
MWD \< 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) \<2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin \<1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
QTc \<450 msec\* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be \<480msec\* on baseline ECG.

Criterios de exclusión

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) \> 35
known or suspected history of alcohol or drug abuse within the last 2 years

Intervenciones

drug

losmapimod

comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg

drug

placebo

placebo comparison with active

Ubicaciones

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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