Estudio de 26 semanas, aleatorizado, doble ciego, multicéntrico, de grupos paralelos para evaluar la eficacia y seguridad de QVA149 (110/50 μg una vez al día) versus tiotropio (18 µg una vez al día) + salmeterol/propionato de fluticasona CDF (50/500 µg dos veces al día) en pacientes con EPOC moderada a grave

CompletadoFase 4ClinicalTrials.gov

ID: NCT02603393Tipo: INTERVENTIONALInicio: 20 de nov de 2015Fin estimado: 18 de jul de 2017

Resumen

Este estudio evaluará la eficacia y seguridad de QVA149 (110/50 μg una vez al día) versus tiotropio (18 µg una vez al día) + salmeterol/propionato de fluticasona CDF (50/500 µg dos veces al día) en pacientes con EPOC moderada a grave.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
Male and female adults aged ≥ 40 years.
Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
Patients with a post-bronchodilator FEV1 ≥40 and \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC \< 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).

Criterios de exclusión

Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.

Intervenciones

drug

QVA149

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI

drug

Tiotropium

Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®

drug

Salmeterol/fluticasone

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Lanús, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

Concepción del Uruguay, Entre Ríos Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Argentina

Novartis Investigative Site

Mendoza, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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