Estudio de 26 semanas de tratamiento, multicéntrico, aleatorizado, doble ciego, doble simulación, controlado con placebo, adaptativo, de diseño continuo, de grupos paralelos, para evaluar la eficacia, seguridad y tolerabilidad de dos dosis de indacaterol (seleccionadas de 75, 150, 300 y 600 µg una vez al día) en pacientes con enfermedad pulmonar obstructiva crónica utilizando formoterol cegado (12 µg dos veces al día) y tiotropio abierto (18 µg una vez al día) como controles activos

CompletadoFase 3ClinicalTrials.gov

ID: NCT00463567Tipo: INTERVENTIONALInicio: 1 de abr de 2007Fin estimado: 1 de ago de 2008

Resumen

La etapa 1 del estudio está diseñada para proporcionar datos sobre la relación riesgo-beneficio de 4 regímenes de dosis de indacaterol (75, 150, 300 y 600 µg una vez al día) con el fin de seleccionar dos dosis para continuar en la etapa 2 del estudio. La etapa 2 del estudio proporcionará confirmación fundamental de la eficacia, seguridad y tolerabilidad de las dosis seleccionadas de indacaterol en pacientes con EPOC.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:
Smoking history of at least 20 pack years
Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value.
Post-bronchodilator FEV1/FVC \< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Criterios de exclusión

Pregnant or lactating females
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long term oxygen therapy (\> 15 h a day)
Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
Patients with a history of asthma (with further criteria)
Patients with Type I or uncontrolled Type II diabetes
Patients with contraindications for tiotropium
Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
Patients with a history of long QT syndrome or whose QTc interval is prolonged
Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
Patients who have had treatment with the investigational drug (with further criteria)
Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
Patients with known history of non compliance to medication
Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Intervenciones

drug

Indacaterol

In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

drug

Formoterol (12 µg b.i.d.)

Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

drug

Tiotropium (18 µg o.d.)

Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.

drug

Placebo to Indacaterol

In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

drug

Placebo to Formoterol

In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

Ubicaciones

Novartis Investigator Site

Buenos Aires, Argentina

Novartis

Buenos Aires, Argentina

Novartis Investigator Site

Capital Federal, Argentina

Novartis Investigator Site

Santa Fe, Argentina

Patrocinadores

PrincipalNovartis

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