A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

CompletadoFase 3ClinicalTrials.gov

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

Traducción no disponible, mostrando original

Resumen

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

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