A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

CompletadoFase 3ClinicalTrials.gov

ID: NCT00144339Tipo: INTERVENTIONALInicio: 1 de dic de 2002

Traducción no disponible, mostrando original

Resumen

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Written informed consent.
Male or female patients 40 years of age or older.
Smoking history of at least 10 pack years.
Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1\<70% of FVC and on stable respiratory medication.

Criterios de exclusión

Respiratory infection in 4 weeks prior to screening.
Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
Myocardial infarction in past 6 months.
Unstable or life threatening arrhythmia in past year.
Hospitalization for NYHA heart failure class III or IV in past year.
Active tuberculosis.
Asthma.
Pulmonary resection.
Malignancy treated with radiation or chemotherapy in past 5 years.
Known hypersensitivity to anticholinergic drugs or components.
Known moderate to severe renal impairment.
Known narrow angle glaucoma.
Significant symptomatic BPH or bladder neck obstruction.
Need for oxygen therapy \>12 hr/day.
Use of oral corticosteroids at unstable doses or \>10 mg/day.

Intervenciones

drug

tiotropium

drug

placebo

Ubicaciones

205.235.101

Buenos Aires, Argentina

205.235.101 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

205.235.103 Hospital Alemán

Capital Federal, Argentina

205.235.104 Hospital de Clinicas José de San Martín

Capital Federal, Argentina

205.235.105 Hospital General de Agudos José María Ramos Mejía

Capital Federal, Argentina

205.235.107 Policlínica Bancaria

Capital Federal, Argentina

205.235.108 Hospital General de Agudos Dr. Enrique Tornú

Capital Federal, Argentina

205.235.109 Hospital Muñiz

Capital Federal, Argentina

205.235.110 Hospital Privado - Centro Médico de Córdoba S.A.

Parque Velez Sarlfield, Argentina

205.235.102 Instituto Cardiovascular de Rosario

Rosario, Argentina

205.235.106 Hospital Cetrángolo

Vicente López, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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