- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03704896
PRospective Observational Multicentre Study on VAriability of Lung Function in Stable PCD Patients (PROVALF-PCD)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 Personal experience and unpublished small retrospective assessments suggest that there is considerable variability.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).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Hampshire
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Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
- University of Southampton
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intra-individual variability of FEV1 z-scores
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Inter-individual variability of FEV1 z-scores
Tidsramme: up to one-year follow-up period
|
Inter-individual variations between repeated measures of lung function parameters.
|
up to one-year follow-up period
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PROVALF
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Primær ciliær dyskinesi
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Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisAfsluttetExcitabilitet af diaphragmatic Primary Motor CortexFrankrig
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OCHIN, Inc.University of FloridaUkendtAkutafdelingens udnyttelse | Primary Care Quality Metrics | Børnebesøg i de første 15 måneder af livet NQF 1392 | Diabetes mellitus NQF 0059 | Screening af kolorektal cancer NQF 0034 | Alkohol- og stofscreening
Kliniske forsøg med Lung function measurement
-
University Hospital, GhentUniversity GhentRekrutteringSund og rask | Skulderarthropati forbundet med andre tilstandeBelgien
-
Pharus Taiwan, Inc.Rekruttering
-
AidenceRekruttering
-
TaiHao Medical Inc.Aktiv, ikke rekrutterende
-
London Health Sciences CentreUkendt
-
Inonu UniversityAfsluttetRygning | Iltmangel
-
KU LeuvenUkendtLungebetændelse, viral | Lungebetændelse | Graviditetsrelateret | Graviditet, høj risiko | COVID | Diagnostiserer sygdom | Graviditetskomplikationer, smitsom | GraviditetssygdomBelgien, Italien, Det Forenede Kongerige
-
Concordia University, MontrealCanadian Institutes of Health Research (CIHR)RekrutteringAldring | Aldersrelateret høretabCanada
-
Xinhua Hospital, Shanghai Jiao Tong University...Aktiv, ikke rekrutterende