Resumen

El propósito de este estudio fue comparar las tasas de flujo inspiratorio dinámico alcanzadas por una población de pacientes con enfermedad pulmonar obstructiva crónica (EPOC) a través de los dispositivos inhaladores de polvo seco (DPI) Breezhaler®, Ellipta® y Handihaler®. No se administró fármaco activo ni placebo a los pacientes en este estudio.

Descripción detallada

Las tasas de flujo inspiratorio alcanzadas por los pacientes con EPOC, a través de los dispositivos actuados por la respiración, son uno de los factores importantes que pueden influir en la eficiencia de la administración del fármaco por vía inhalatoria. Las tasas de flujo inspiratorio máximo (PIF) alcanzadas por los pacientes con EPOC a través de diferentes inhaladores de polvo seco actuados por la respiración pueden diferir debido a las diferencias en la resistencia interna de los distintos tipos de dispositivos. Los resultados de la tasa de flujo de aire inspiratorio y la caída de presión a lo largo del tiempo, de este estudio, proporcionaron una evaluación del rango y la variabilidad de las características del perfil de inhalación generadas por los pacientes con EPOC dentro de la población seleccionada para este estudio (por ejemplo, datos demográficos, sexo, control de la enfermedad) a través del Breezhaler y los otros DPI comparadores comercializados. Los perfiles de inhalación se obtuvieron a través de un registrador de perfil de inhalación (IPR). El registrador de perfil de inhalación era un dispositivo de adquisición de datos que consiste en una computadora, una unidad de interfaz y un transductor de presión. Esto le permitía medir la caída de presión dinámica en tiempo real en la boquilla del inhalador durante una maniobra de inhalación. En la interfaz gráfica de usuario se mostraban en tiempo real gráficos de caída de presión inspiratoria versus tiempo y tasa de flujo versus tiempo. El investigador o el personal del estudio designado en el sitio era responsable de ingresar la ubicación de la prueba, seleccionar el tipo de inhalador (Breezhaler, Ellipta, Handihaler), ingresar la identificación y la edad del paciente, seleccionar masculino o femenino, y registrar los comentarios del paciente realizados durante la sesión de prueba, según fuera necesario. Cada paciente debía generar tres (03) perfiles de inhalación a través de cada uno de los tres (03) dispositivos del estudio: Breezhaler®, Ellipta® y Handihaler®.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

\- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
Note: A pack of cigarettes is equal to 20 cigarettes. Occasional smoking of cigars is not relevant to smoking history.
An ex-smoker is defined as a patient who has not smoked for ≥6 months at screening.
COPD patients with moderate to very severe airflow limitation (spirometric classification: GOLD 2, 3 or 4) at time of screening,
Post-bronchodilator FEV1 \< 80% of the predicted normal, and
Post-bronchodilator FEV1/forced vital capacity (FVC) \<0.70. (Post-bronchodilator refers to 1 hour after sequential inhalation of 84 µg ipratropium bromide and 400 µg salbutamol)
Willing patients assessed as suitable by investigator to reproducibly perform inhalational manoeuvers through study devices as required by the standard protocol
Willing patients assessed as suitable by investigator to comprehend and follow the instructions for use of the inhalational devices to be tested in the study

Criterios de exclusión

Patients with a history of asthma or onset of respiratory symptoms prior to the age of 40 years
Use of short acting bronchodilating agent (SABA) as rescue (reliever) medication within 6 hours prior to or during inhalational profile assessments for the study \[Note: Use of rescue medication should not be restricted if patient feels the need of the rescue/ reliever medication because of the diseased state. Safety and disease management should be priority and the suitability of such a patient for the study or relevance of the (study) assessments done for the study should be reviewed, as appropriate.\]
Patients with any history of premature birth less than 33 weeks gestation or significant level of respiratory care including mechanical ventilation required as neonate affecting the respiratory tract or chronic lung diseases, which in the opinion of the investigator or designated study personnel at site may interfere with the study evaluation or optimal participation in the study.
Any major chronic illness including but not limited to a diagnosis of non-skin cancer, cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder).
Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening
Patients who, within 7 days prior to the screening visit (Visit 1) OR prior to Visit 2, increased use of rescue bronchodilators amounting to more than double the average number of puffs used in the preceding week or more than 8 puffs of SABA on any 3 consecutive days or more than 12 puffs of SABA on any 2 consecutive days
Respiratory tract infections (sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection) within the 4weeks before the visit

Intervenciones

device

Breezhaler®

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.

device

Ellipta®

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.

device

Handihaler®

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Florida, Buenos Aires, Argentina

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

Estudio multicéntrico, abierto, cruzado, para comparar las tasas de flujo inspiratorio alcanzadas por pacientes con EPOC a través de los dispositivos inhaladores de polvo seco Breezhaler®, Ellipta® y Handihaler®.

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Breezhaler®

Ellipta®

Handihaler®

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores