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Primary Ciliary Dyskinesia in Adult Bronchiectasis

27. april 2026 opdateret af: Michael D. Davis, Indiana University

Novel Use of Combined High-Speed Video Microscopy and Nasal Nitric Oxide Screening for Identification of Primary Ciliary Dyskinesia in Adult Bronchiectasis

The purpose of this study is to help determine how often primary ciliary dyskinesia (PCD) is present but undiagnosed in adults with bronchiectasis.

Studieoversigt

Detaljeret beskrivelse

Bronchiectasis is a chronic respiratory disease characterized by irreversible bronchial dilatation, impaired mucociliary clearance, and recurrent infection. Despite comprehensive evaluation, 40-80% of adults with non-cystic fibrosis (CF) bronchiectasis have no identifiable cause. This diagnostic absence limits opportunities for targeted therapy, individualized prognostication, and potential genetic counseling.

Primary ciliary dyskinesia (PCD) is an inherited disorder of motile cilia that leads to chronic otosinopulmonary disease. Nearly 100% of affected individuals develop bronchiectasis by adulthood (4). Diagnosis is complex with no 'gold standard' test and requires multiple specialized diagnostics-most available only at large referral centers. In current North American practice, evaluation of suspected PCD frequently begins with measurement of nasal nitric oxide (nNO), an accurate screening tool when performed correctly. However, testing errors occur due to discrepancies in technique, and false negatives are well-described in a growing list of PCD genotypes harboring preserved ciliary ultrastructure, as well as in select primary immunodeficiencies.

High-speed video microscopy analysis (HSVA) is a key PCD diagnostic tool that directly visualizes ciliary beating ex vivo, providing detailed assessment of ciliary beat frequency, waveform, and pattern. As a functional assay, HSVA has substantial diagnostic value in cases where PCD would otherwise remain unrecognized (e.g., patients with normal nNO, normal/nondiagnostic transmission electron microscopy (TEM), or incomplete genetic testing). When performed using standardized protocols and blinded review, multicenter studies demonstrate excellent diagnostic performance, with sensitivities and specificities of of 96-100% and 91-96% respectively. Air-liquid interface (ALI) culture further refines accuracy by differentiating inherent ciliary defects from secondary, inflammation-induced abnormalities.

Growing evidence suggests that PCD remains significantly underrecognized worldwide. Large-scale genomic analyses now estimate a global prevalence as high as 1 in 7,500-two to four times higher than previous estimates. These findings are amplified in adults with bronchiectasis: a recent genomic sequencing study of patients with idiopathic bronchiectasis revealed that more than 10% carried pathogenic variants in motile ciliopathy genes, yet the vast majority had never undergone targeted testing for PCD.

Collectively, these data indicate that a substantial proportion of adults with bronchiectasis may have undiagnosed PCD. Identifying this population has meaningful clinical implications. Confirmation of PCD enables precise airway clearance and infection-control strategies, recognition and treatment of potential cardiac and multi-organ manifestations, and appropriate genetic counseling. Moreover, as disease-modifying and gene-targeted therapies advance toward clinical use, timely and accurate diagnosis will be essential to ensuring equitable access to emerging treatments.

Hypothesis: Unrecognized PCD is prevalent within a significant and measurable proportion of adults with non-CF bronchiectasis. The combined use of upfront nNO and HSVA of ALI-cultured ciliated nasal epithelia represents a unique, highly sensitive, and potentially diagnostic method to help identify this patient population.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Lisa Bendy
  • Telefonnummer: (317) 278-7152
  • E-mail: lbendy@iu.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults (≥18) with CT-confirmed bronchiectasis

Exclusion Criteria:

  • Pre-existing diagnosis of cystic fibrosis
  • Pre-existing diagnosis of primary ciliary dyskinesia
  • Inability to perform testing
  • Refusal of consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bronchiectasis
patients with a known or new diagnosis of bronchiectasis
Subjects will have their nasal nitric oxide measured using commercially available chemiluminescence analyzer in accordance with American Thoracic Society/European Respiratory Society guidelines
Human nasal epithelial cells will be collected via nasal swab, nasal curettage or nasal brush from each nostril.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants with a screen positive result
Tidsramme: From Baseline through study completion, approximately two years.
Percentage of participants with a screen positive result. This will be defined as abnormal nNO and/or abnormal HSVA and confirmatory genetic testing or TEM findings of classic pathogenic variants.
From Baseline through study completion, approximately two years.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. januar 2028

Studieafslutning (Anslået)

31. januar 2028

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 29887

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No IPD will be shared

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Idiopatisk bronkiektasi

Kliniske forsøg med Nasal Nitric Oxide Measurement

Abonner