A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00796653Tipo: INTERVENTIONALInicio: 1 de ene de 2009

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1\<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC \<70% at Visit 1
Male or female patients, 40 years of age or older
Patients must be current or ex-smokers with a smoking history of more than 10 pack years:

Criterios de exclusión

Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN
Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)
Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
Patients who have undergone thoracotomy with pulmonary resection
Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
Patients who regularly use daytime oxygen therapy for more than one hour per day.
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
Pregnant or nursing women
Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

Intervenciones

drug

Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

drug

Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

drug

Formoterol

Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients

drug

Placebo

Placebo devices for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Ubicaciones

1222.14.5004 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1222.14.5003 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1222.14.5001 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

1222.14.5002 Boehringer Ingelheim Investigational Site

Quilmes, Argentina

1222.14.5005 Boehringer Ingelheim Investigational Site

San Juan Bautista, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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 Randomised, Double-blind, Double-dummy, Placebo-control... | EligiMed