A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

CompletadoFase 3ClinicalTrials.gov

ID: NCT00393458Tipo: INTERVENTIONALInicio: 1 de oct de 2006Fin estimado: 1 de jul de 2008

Traducción no disponible, mostrando original

Resumen

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
Smoking history of at least 20 pack years
Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

Criterios de exclusión

Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
Patients who 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 co-morbid conditions.

Intervenciones

drug

Indacaterol

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

drug

Formoterol

Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

drug

Placebo to indacaterol

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

drug

Placebo to formoterol

Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

Ubicaciones

Novartis Investigator Site

Buenos Aires, Argentina

Novartis

Buenos Aires, Argentina

Novartis Investigator Site

Mendoza, Argentina

Novartis Investigator Site

San Miguel, Argentina

Novartis Investigator Site

Santa Fe, Argentina

Patrocinadores

PrincipalNovartis

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