Ensayo aleatorizado, doble ciego, controlado con placebo, de dos años de duración, para examinar los cambios en la resistencia al ejercicio y la EPOC tratada con tiotropio una vez al día (EXACTT)

CompletadoFase 4ClinicalTrials.gov

ID: NCT00525512Tipo: INTERVENTIONALInicio: 1 de ago de 2007

Resumen

El objetivo de este estudio es evaluar los efectos sobre la duración del ejercicio de 96 semanas de tratamiento con tiotropio 18 mcg (Spiriva HandiHaler) una vez al día, en comparación con placebo, en pacientes con EPOC.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

All patients must sign an informed consent
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Age \>= 40 years
Medical Research Council Dyspnoea score \>= 2
Current or ex-smoker with a \>= 10 pack-year smoking history
Ability to exercise on treadmill

Criterios de exclusión

Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Clinical history of asthma
Use of supplemental oxygen therapy
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Recent history (\<= 12 months) of myocardial infarction
Unstable or life-threatening cardiac arrhythmia
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Pregnant or nursing women
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Estimated life expectancy \< 2 years
Symptomatic prostatic hyperplasia or bladder neck obstruction
Known narrow-angle glaucoma
Any condition that is contraindicated for exercise
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space

Intervenciones

drug

tiotropium 18 mcg

Oral inhalation once daily of 18mcg tiotropium via handihaler

drug

Placebo

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Ubicaciones

205.368.54001 Boehringer Ingelheim Investigational Site

Rosario, Argentina

205.368.54002 Boehringer Ingelheim Investigational Site

Vicente López, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

ColaboradorPfizer

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.

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