- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07566611
Primary Ciliary Dyskinesia in Adult Bronchiectasis
Novel Use of Combined High-Speed Video Microscopy and Nasal Nitric Oxide Screening for Identification of Primary Ciliary Dyskinesia in Adult Bronchiectasis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kenzie Mahan
- Telefonní číslo: 3172748899
- E-mail: krmahan@iu.edu
Studijní záloha kontaktů
- Jméno: Lisa Bendy
- Telefonní číslo: (317) 278-7152
- E-mail: lbendy@iu.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of participants with a screen positive result
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Shapiro AJ, Zariwala MA, Ferkol T, Davis SD, Sagel SD, Dell SD, Rosenfeld M, Olivier KN, Milla C, Daniel SJ, Kimple AJ, Manion M, Knowles MR, Leigh MW; Genetic Disorders of Mucociliary Clearance Consortium. Diagnosis, monitoring, and treatment of primary ciliary dyskinesia: PCD foundation consensus recommendations based on state of the art review. Pediatr Pulmonol. 2016 Feb;51(2):115-32. doi: 10.1002/ppul.23304. Epub 2015 Sep 29.
- Leigh MW, Pittman JE, Carson JL, Ferkol TW, Dell SD, Davis SD, Knowles MR, Zariwala MA. Clinical and genetic aspects of primary ciliary dyskinesia/Kartagener syndrome. Genet Med. 2009 Jul;11(7):473-87. doi: 10.1097/GIM.0b013e3181a53562.
- Shoemark A, Griffin H, Wheway G, Hogg C, Lucas JS; Genomics England Research Consortium; Camps C, Taylor J, Carroll M, Loebinger MR, Chalmers JD, Morris-Rosendahl D, Mitchison HM, De Soyza A; Genomics England Research Consortium:; Brown D, Ambrose JC, Arumugam P, Bevers R, Bleda M, Boardman-Pretty F, Boustred CR, Brittain H, Caulfield MJ, Chan GC, Fowler T, Giess A, Hamblin A, Henderson S, Hubbard TJP, Jackson R, Jones LJ, Kasperaviciute D, Kayikci M, Kousathanas A, Lahnstein L, Leigh SEA, Leong IUS, Lopez FJ, Maleady-Crowe F, McEntagart M, Minneci F, Moutsianas L, Mueller M, Murugaesu N, Need AC, O'Donovan P, Odhams CA, Patch C, Perez-Gil D, Pereira MB, Pullinger J, Rahim T, Rendon A, Rogers T, Savage K, Sawant K, Scott RH, Siddiq A, Sieghart A, Smith SC, Sosinsky A, Stuckey A, Tanguy M, Taylor Tavares AL, Thomas ERA, Thompson SR, Tucci A, Welland MJ, Williams E, Witkowska K, Wood SM. Genome sequencing reveals underdiagnosis of primary ciliary dyskinesia in bronchiectasis. Eur Respir J. 2022 Nov 17;60(5):2200176. doi: 10.1183/13993003.00176-2022. Print 2022 Nov.
- Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.
- Lucas JS, Barbato A, Collins SA, Goutaki M, Behan L, Caudri D, Dell S, Eber E, Escudier E, Hirst RA, Hogg C, Jorissen M, Latzin P, Legendre M, Leigh MW, Midulla F, Nielsen KG, Omran H, Papon JF, Pohunek P, Redfern B, Rigau D, Rindlisbacher B, Santamaria F, Shoemark A, Snijders D, Tonia T, Titieni A, Walker WT, Werner C, Bush A, Kuehni CE. European Respiratory Society guidelines for the diagnosis of primary ciliary dyskinesia. Eur Respir J. 2017 Jan 4;49(1):1601090. doi: 10.1183/13993003.01090-2016. Print 2017 Jan.
- Ringshausen FC, de Roux A, Diel R, Hohmann D, Welte T, Rademacher J. Bronchiectasis in Germany: a population-based estimation of disease prevalence. Eur Respir J. 2015 Dec;46(6):1805-7. doi: 10.1183/13993003.00954-2015. Epub 2015 Aug 20. No abstract available.
- Raidt J, Krenz H, Tebbe J, Grosse-Onnebrink J, Olbrich H, Loges NT, Biebach L, Schmalstieg C, Kessler C, Wallmeier J, Dworniczak B, Pennekamp P, Dugas M, Werner C, Omran H. Limitations of Nasal Nitric Oxide Measurement for Diagnosis of Primary Ciliary Dyskinesia with Normal Ultrastructure. Ann Am Thorac Soc. 2022 Aug;19(8):1275-1284. doi: 10.1513/AnnalsATS.202106-728OC.
- Hannah WB, Seifert BA, Truty R, Zariwala MA, Ameel K, Zhao Y, Nykamp K, Gaston B. The global prevalence and ethnic heterogeneity of primary ciliary dyskinesia gene variants: a genetic database analysis. Lancet Respir Med. 2022 May;10(5):459-468. doi: 10.1016/S2213-2600(21)00453-7. Epub 2022 Jan 17.
- Barber AT, Davis SD, Boutros H, Zariwala M, Knowles MR, Leigh MW. Use caution interpreting nasal nitric oxide: Overlap in primary ciliary dyskinesia and primary immunodeficiency. Pediatr Pulmonol. 2021 Dec;56(12):4045-4047. doi: 10.1002/ppul.25636. Epub 2021 Sep 2. No abstract available.
- Popatia R, Haver K, Casey A. Primary Ciliary Dyskinesia: An Update on New Diagnostic Modalities and Review of the Literature. Pediatr Allergy Immunol Pulmonol. 2014 Jun 1;27(2):51-59. doi: 10.1089/ped.2013.0314.
- Shoemark A, Goutaki M, Kinghorn B, Ardura-Garcia C, Baz-Redon N, Chilvers M, Davis SD, De Brandt J, Dell S, Dhar R, Dixon L, Ferkol T, Hogg C, Legendre M, Leigh M, Lucas JS, Manion M, Rumman N, Toews I, Labonte V, Wee WB, Kouis P, Horani A. European Respiratory Society and American Thoracic Society guidelines for the diagnosis of primary ciliary dyskinesia. Eur Respir J. 2025 Dec 18;66(6):2500745. doi: 10.1183/13993003.00745-2025. Print 2025 Dec.
- Rubbo B, Shoemark A, Jackson CL, Hirst R, Thompson J, Hayes J, Frost E, Copeland F, Hogg C, O'Callaghan C, Reading I, Lucas JS; National PCD Service, UK. Accuracy of High-Speed Video Analysis to Diagnose Primary Ciliary Dyskinesia. Chest. 2019 May;155(5):1008-1017. doi: 10.1016/j.chest.2019.01.036. Epub 2019 Feb 28.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
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