Estudio de eficacia de fase IIIb, multicéntrico, de 52 semanas de tratamiento, aleatorizado, cegado, de doble simulación, de grupos paralelos, que compara el efecto de indacaterol inhalado 150 µg una vez al día versus tiotropio inhalado 18 µg una vez al día sobre la función pulmonar, la tasa de exacerbaciones y resultados relacionados en pacientes con EPOC

CompletadoFase 3ClinicalTrials.gov

ID: NCT00845728Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de jul de 2012

Resumen

Este estudio compara indacaterol con tiotropio en términos de broncodilatación durante 52 semanas.

Edad mínima: 40 YearsSexo: ALL

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
Smoking history of at least 10 pack years, both current and ex-smokers are eligible
A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

drug

Indacaterol 150 µg o.d. delivered via SDDPI

drug