A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT00846586Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de mar de 2010

Traducción no disponible, mostrando original

Resumen

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) and:
Smoking history of at least 10 pack-years
Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (force vital capacity) \< 70%

Criterios de exclusión

Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization 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 or during the run-in period
Patients with a body mass index less than 15 or more than 40 kg/m\^2
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

Intervenciones

drug

Indacaterol 150 μg

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

drug

Tiotropium 18 μg

Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).

drug

Placebo to indacaterol

Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative SIte

Mendoza, Argentina

Novartis Investigative Site

Rosario, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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