Este estudio fue diseñado para investigar la eficacia y seguridad a 1 año de la dosis de 50 µg una vez al día (od) de bromuro de glicopirronio (NVA237) en pacientes con enfermedad pulmonar obstructiva crónica moderada a grave.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2 (Day -14).
Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1).

Criterios de exclusión

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
Patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females.

Intervenciones

drug

Glycopyrronium bromide

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

drug

Placebo to glycopyrronium bromide

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

drug

Tiotropium

Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

La Plata - Bueno Aire, Argentina

Novartis Investigative Site

Parana Entre Rios, Argentina

Novartis Investigative Site

Rosario, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Estudio de grupos paralelos, aleatorizado, doble ciego, controlado con placebo y con tiotropio en etiqueta abierta, de 52 semanas de tratamiento, para evaluar la eficacia, seguridad y tolerabilidad de bromuro de glicopirronio (NVA237) en pacientes con enfermedad pulmonar obstructiva crónica

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Glycopyrronium bromide

Placebo to glycopyrronium bromide

Tiotropium

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores