- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03704896
PRospective Observational Multicentre Study on VAriability of Lung Function in Stable PCD Patients (PROVALF-PCD)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background
Lung function measurements are commonly used in PCD to monitor disease progression. Spirometry measurements are taken every 3 months and results are compared to established references, adjusted for age, height and ethnicity. Results are also compared to previous measurements from the same patient at earlier appointments. However, little is understood of the impact of intra-individual variability and the extent of spontaneous variations in these comparisons.
One of the priorities for respiratory research in the UK is to understand factors involved in determining different outcomes for lung function.[1] The precision of measurements done on the same individual conducted by different people, in different settings and using different equipment is not entirely known. Importantly, previous studies in healthy children assessing intra-individual variability have shown variations of up to 1.2 z-scores in spirometry parameters over the course of 1 year.[2] Within test-variability and daily repeatability can range from 2 to10% FEV% predicted in young healthy children.[3],[4]
In PCD, deterioration of lung function does not follow a pre-defined pattern.[5] However, none of the published studies on lung function in PCD to date have taken into consideration the imprecision of individual and repeated measurements on the same individual over time. Personal experience and unpublished small retrospective assessments suggest that there is considerable variability.
Key research question
Quantify intra-individual (i.e. in the same individual) variations between measurements of lung function in stable patients with primary ciliary dyskinesia (PCD), a rare genetic disease that causes lung damage.
Study design
Prospective multicentre cohort study using routinely collected clinical data to evaluate natural variability of lung function measurements in stable PCD patients.
The primary end-point is to assess intra-individual variations between repeated measures of lung function parameters. Secondary end-points include: a) Inter-individual variations between repeated measures of lung function parameters and correlations with baseline measures; b) intra- and inter-individual variation between repeated measures of lung function parameters during exacerbation.
Participants will be approached by their clinicians and asked to sign a consent form to allow for their anonymised routinely collected clinical data to be entered into the study. Routine clinical data will be collected at PCD follow-up clinics in participating centres. These data are already collected for clinical purposes and will be anonymised locally. Non-identifiable data will be entered into the study database by a member of the clinical team of the participating centre. The study coordinating centre (University of Southampton) will only have access to the anonymised dataset.
The data collection period will last 18 months (6 months for patients recruitment and 12 months for patient follow-up).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Hampshire
-
Southampton, Hampshire, Reino Unido, SO16 6YD
- University of Southampton
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Children (>5 years of age) and adults being follow-up for PCD
- Availability of at least minimal dataset (spirometry data), at least every 6 months
- Outpatients and/or in-patients
Exclusion Criteria:
- Children < 5 years of age
- Regular interval between spirometry testing > 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intra-individual variability of FEV1 z-scores
Periodo de tiempo: up to one-year follow-up period
|
Natural intra-individual variability of FEV1 z-score in patients that are not experiencing an episode of chest exacerbation at the time of lung function measurement.
|
up to one-year follow-up period
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Inter-individual variability of FEV1 z-scores
Periodo de tiempo: up to one-year follow-up period
|
Inter-individual variations between repeated measures of lung function parameters.
|
up to one-year follow-up period
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Manifestaciones neurológicas
- Anomalías congénitas
- Enfermedades Genéticas Congénitas
- Enfermedades Otorrinolaringológicas
- Trastornos del movimiento
- Anomalías Múltiples
- Ciliopatías
- Discinesias
- Trastornos de la motilidad ciliar
Otros números de identificación del estudio
- PROVALF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lung function measurement
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoPérdida de la audición | Función cognitiva | Función ejecutiva | Función vestibularFrancia
-
contextflow GmbHTerminado
-
University of Colorado, DenverInivataRetiradoCáncer de pulmón de células no pequeñasEstados Unidos
-
Navigation Sciences, Inc.Activo, no reclutando
-
Mayo ClinicTerminadoTrasplante de PulmónEstados Unidos
-
University of ZurichRetiradoTrasplante de Pulmón | Disfunción crónica del aloinjerto de pulmón | Trasplante de pulmón de rechazo
-
Dartmouth-Hitchcock Medical CenterAmerican Academy of Medical AcupunctureReclutamiento
-
Stuart SchembriTerminado
-
The University of Hong KongTerminado