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Remodelling of the Lower Airways in Chronic Cough

15. juni 2026 oppdatert av: Medical University of Warsaw

Does Chronic Cough Lead to Injury and Remodelling of the Lower Airways?

The aim of the study is to assess if chronic cough leads to injury and remodelling of the airways. We plan to analyse bronchial injury and remodelling in patients with refractory chronic cough lasting longer than 12 month . Assessment of injury mediators will be performed in blood and bronchoalveolar lavage fluid. Remodelling features will be analysed based on chest CT scan and pathologic specimens. Injury of epithelium will be assessed in bronchial biopsy specimens. The relationship between the duration, severity of chronic cough, and bronchial inflammation, damage, remodelling will be analysed.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cough is a physiological defensive reflex which decreases the risk of aspiration to the lower airways and allows to remove sputum and excessive mucus from the airways. However, in some cases, persisting intensive cough may result in many complications and decrease in patients' quality of life. Damage of the airway epithelium due to infection, chemical or mechanical injury leads to an increase in the frequency or intensity of cough.

The aim of the study is to assess if chronic cough leads to damage and remodelling of the airways. We plan to analyse bronchial injury and remodelling in patients with refractory chronic cough lasting longer than 12 months. Assessment of injury mediators will be performed in blood and BALF. Remodelling will be analysed based on chest CT scan and pathologic specimens. Injury of epithelium will be assessed in pathologic specimens of bronchial biopsy. The relationship between the duration, severity of chronic cough and bronchial inflammation, damage, remodelling will be analysed.

Patients with refractory chronic cough and clinical indications for bronchoscopy (such as: productive cough, mucus plugs or bronchiectasis in chest CT, suspected extensive dynamic airway collapse (EDAC), assessment of eosinophilic airway inflammation when induced sputum could not be obtained, or any suspicion or high risk of malignancy) will be invited to take part in the study.

We plan to enroll 40 non-smoking patients with chronic cough lasting longer than 12 months, who had already been unsuccessfully treated because of cough. Thorough diagnostics of cough reason will be performed. Besides parameters of bronchial inflammation, remodelling and injury will be analysed in serum and BALF. Injury and remodelling will also be assessed in bronchial biopsy and in chest CT.

The results of the study will assess if refractory chronic cough is associated with any type of airway inflammation, bronchial injury or remodeling.

Studietype

Observasjonsmessig

Registrering (Antatt)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Marta Dąbrowska, MD, PhD
  • Telefonnummer: +48 501157765
  • E-post: mdabrowska@mp.pl

Studer Kontakt Backup

  • Navn: Karolina Klimowicz, MD
  • Telefonnummer: +48 507045417
  • E-post: mdabrowska@mp.pl

Studiesteder

  • Polen
      • Warsaw, Polen, 02-091
        • Rekruttering
        • Medical University of Warsaw
        • Ta kontakt med:
      • Warsaw, Polen, 02-097
        • Rekruttering
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Ta kontakt med:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-097
        • Rekruttering
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Ta kontakt med:
          • Marta Dąbrowska, MD, PhD
          • Telefonnummer: +48 501157765
          • E-post: mdabrowska@mp.pl
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marta Dąbrowska, MD, PhD
        • Underetterforsker:
          • Karolina Klimowicz, MD
    • Warsaw
      • Warsaw, Warsaw, Polen, 02-097
        • Rekruttering
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marta Dąbrowska, MD, PhD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

In 30 patients referred to the cough clinic for refractory chronic cough lasting more than 6 months

Beskrivelse

Inclusion criteria for the study group:

  1. age between 18 and 75 years,
  2. chronic cough of at least one year duration, with no previous treatment (at least 2 previous unsuccessful attempts at pharmacological treatment of cough)
  3. negative history of smoking (at least 6 months of abstinence),
  4. negative history of treatment with angiotensin-converting enzyme inhibitors (ACEI),
  5. normal chest radiograph or with changes not relevant to cough formation,
  6. no respiratory tract infections in the past 6 weeks,
  7. written consent from the patient to participate in the study.

Exclusion Criteria:

  1. patients less than 18 and more than 75 years of age,
  2. cough lasting less than 12 months,
  3. active smoking or abstinence period of less than 6 months,
  4. respiratory tract infection 6 weeks prior to inclusion or at the time of study conduct - retry inclusion after 6 weeks,
  5. cancer or interstitial lung disease,
  6. contraindications to functional testing, sputum induction or bronchoscopy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
40 patients with refractory chronic cough lasting more than 6 months.

Patients were eligible for inclusion if they:

were 18-75 years old; had chronic cough lasting more than 12 months unresponsive to previous treatment presented with a normal or near normal chest radiograph or only abnormalities irrelevant to cough; and had clinical indications for bronchoscopy
Diagnostisk test: chest computed tomography and bronchoscopy

Assessment of airway remodeling features on chest CT in patients with chronic cough.

Evaluation of airway injury and remodeling based on biological specimens obtained from the lower airways during bronchoscopy.Bronchoscopy is performed if clinically indicated.

Andre navn:
  • Assessment of airway remodeling features on chest computed tomography
  • Assessment of remodelling in bronchial biopsy or bronchoalveolar lavage fluid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
assessment of the severity of epithelial damage and inflammation in the bronchial biopsy
Tidsramme: baseline
Bronchial biopsy will be analysed for airway inflammation and remodeling features such as proportion of epithelial shedding basement membrane thickening, infiltration of inflammatory cells and subbasement membrane (SBM) thickening.
baseline
assessment of airway inflammation and remodeling in the airways in chest CT
Tidsramme: baseline
The CT scans will be evaluated for the presence, extent, and severity of bronchial wall thickening, bronchiectasis, mucus plugs, centrilobular abnormalities, air trapping or mosaic attenuation.
baseline
Assessment of biomarkers of inflammation in serum and BALF
Tidsramme: baseline
Assessment of cellular composition and inflammatory biomarkers in serum and BALF ( IL-2, IL4, IL-5, IL-8, PGE2, periostin, TSLP),
baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medical University of Warsaw

Etterforskere

  • Studieleder: Rafał Krenke, MD, PhD, Prof, Department of Internal Medicine, Pulmonary Diseases and Allergy, Warsaw Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2022

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

30. august 2026

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Remodelling in CC

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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