A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
4 de julio de 2019 actualizado por: Vectura Limited
An Open-label, Non-drug Methodology Trial to Evaluate the Use of a Mouthpiece With the VR647 Inhalation System During Delivery of Isotonic Saline (0.9% NaCl) in Subjects Less Than Five Years of Age Who Have Previously Received an Inhaled Therapy Delivered Either by a Nebulizer or by a Pressurized Metered-dose Inhaler Plus Spacer
This is an open-label, non-drug methodology trial in which subjects undergo a stepwise series of tests to evaluate their ability to use a mouthpiece to deliver nebulized therapy.
The trial consists of a screening assessment and familiarization session, and two nebulization assessments, conducted over two site visits. The screening assessment, familiarization session and first nebulization assessment will take place at Visit 1, while the second nebulization assessment will take place at Visit 2. The total duration between Visits 1 and 2 will be 4 - 8 days. Each visit is expected to last up to 2 hours.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
At the initial visit (Visit 1), eligible subjects (i.e., children) and their parent(s)/legal guardian(s) will be approached to ascertain their interest in trial participation. Interested subjects and their parent(s)/legal guardian(s) will proceed to a nebulizer familiarization session. After informed consent has been obtained from the subject's parent(s)/legal guardian(s), the subject will proceed to Nebulization Assessment 1.
At Nebulization Assessment 1 (Visit 1), all subjects will perform 3 attempts of 19 inhalations, each inhalation of 3 seconds duration. Nebulization Assessment 2 (Visit 2) will occur 4-8 days after Visit 1. Subjects, who failed to achieve nebulization success at Attempt 3 during Visit 1, will perform 3 attempts of 28 inhalations, each inhalation of 2 seconds duration at Visit 2. Subjects, who achieved nebulization success at Attempt 3 during Visit 1, will perform 3 attempts of 14 inhalations, each inhalation of 4 seconds duration at Visit 2.
At each visit, Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl). Nebulization success will be assessed at Attempt 3.
Tipo de estudio
Intervencionista
Inscripción (Actual)
41
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Mission Viejo, California, Estados Unidos, 92691
- Allergy & Asthma Associates of Southern California
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Minnesota
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Plymouth, Minnesota, Estados Unidos, 55441
- Clinical Research Institute, Inc
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607
- North Carolina Clinical Research
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- National Allergy and Asthma Research, LLC
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 año a 5 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female subjects aged 1 to <5 years
- History of coughing and/or recurrent wheezing within the last year, otherwise healthy
- Use of an inhaler with a spacer or nebulizer for at least 30 days (consecutive or otherwise) within the last year. Examples of inhaled or nebulized therapy include the use of a regular controller (inhaled corticosteroids (ICS) or ICS/long-acting beta-agonists), or a reliever therapy (e.g., albuterol) on an as needed basis for the relief of symptoms
- Written informed consent from the subjects's parent(s)/legal guardian(s), including privacy authorization, prior to trial participation
- Subject's parent(s)/legal guardian(s) must be willing and able to comply with the trial procedures and visit schedules
Exclusion Criteria:
Screening (Visit 1)
- Any significant medical conditions (apart from a history of coughing and/or recurrent wheezing) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures
- Subjects with current respiratory symptoms or breathing difficulties at the time of screening
- History of paradoxical bronchospasm or hyper-responsiveness following inhaled therapy that in the opinion of investigator may put the subject at risk when inhaling isotonic saline
- Parent(s)/legal guardian(s) who is an employee of the investigational site or the Sponsor, who is directly involved in the trial, or a family member of such a person
Nebulization Assessment 2 (Visit 2)
- Development of any new illness or condition between the Screening (Visit 1) and prior to Nebulization Assessment 2 (Visit 2) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures
- Any safety concerns that in the opinion of the investigator would jeopardize the subject by his/her continued participation in the trial
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Visit 1 and Visit 2, Test Arm 2A
Subjects who carried out 3 attempts at Visit 1, failed to achieve nebulization success and subsequently were included in Test Arm 2A for Visit 2
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3 attempts of 19 inhalations, 3 second per breath.
Attempts 1 and 2 will be made with air only.
Attempt 3 will be made with isotonic saline (0.9% NaCl)
3 attempts of 28 inhalations, 2 second per breath.
Attempts 1 and 2 will be made with air only.
Attempt 3 will be made with isotonic saline (0.9% NaCl)
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Otro: Visit 1 and Visit 2, Test Arm 2B
Subjects who carried out 3 attempts at Visit 1, achieved nebulization success and were subsequently included in Test Arm 2B for Visit 2
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3 attempts of 19 inhalations, 3 second per breath.
Attempts 1 and 2 will be made with air only.
Attempt 3 will be made with isotonic saline (0.9% NaCl)
3 attempts of 14 inhalations, 4 second per breath.
Attempts 1 and 2 will be made with air only.
Attempt 3 will be made with isotonic saline (0.9% NaCl)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.
Periodo de tiempo: 4 to 8 days
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Nebulization success using a mouthpiece defined as actuating the nebulizer on at least 70% of planned inhalations and inhaling at least 50% of the total intended inhalation volume.
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4 to 8 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit.
Periodo de tiempo: 4 to 8 days
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Number of breaths completed by subjects using a mouthpiece recorded at each visit.
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4 to 8 days
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Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 at each visit.
Periodo de tiempo: 4 to 8 days
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Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist.
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4 to 8 days
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Number of subjects who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 overall and by age (years) at each visit.
Periodo de tiempo: 4 to 8 days
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Number of subjects who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist.
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4 to 8 days
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The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit.
Periodo de tiempo: 4 to 8 days
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The inhalation checklist consists of 5 questions regarding inhalation quality answered Yes/No (Q1, Q2, Q3 and Q5) or by percentage (Q4), with Yes answers for Q1-3 and >50% for Q4 (or Yes answers for Q1-3 and Q5 in the successful subgroup analysis) being scored as perfect.
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4 to 8 days
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Mean modified Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years).
Periodo de tiempo: 4 to 8 days
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The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices.
The modified PASAPQ consists of 10 questions.
The first 8 questions generate the total score domain (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 14.3 to 100, calculated as ((Q1+Q2+Q3+Q4+Q5+Q6+Q7+Q8)/56)*100).
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4 to 8 days
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Mean modified PASAPQ satisfaction score at Attempt 3 at Visit 2 overall and by age (years).
Periodo de tiempo: 4 to 8 days
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The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices.
The modified PASAPQ consists of 10 questions.
Question 9 asks for overall satisfaction with the device(s) used in the trial (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 1-7).
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4 to 8 days
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Mean modified PASAPQ score indicating willingness to continue with the device at Attempt 3 at Visit 2 overall and by age (years).
Periodo de tiempo: 4 to 8 days
|
The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices.
The modified PASAPQ consists of 10 questions.
Question 10 asks about willingness to continue with the device(s) used in the trial (scale: 0 (i.e, not willing) to 100 (i.e., definitely willing; range: 0-100).
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4 to 8 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de noviembre de 2017
Finalización primaria (Actual)
20 de febrero de 2018
Finalización del estudio (Actual)
20 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2019
Primero enviado que cumplió con los criterios de control de calidad
4 de julio de 2019
Publicado por primera vez (Actual)
8 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
4 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VR647/0/003
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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