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NCT Number: NCT07659860

Remodelling of the Lower Airways in Chronic Cough

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Masovian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the study group:

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

Exclusion criteria

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

Treatment and study plan

chest computed tomography and bronchoscopy

Diagnostic Test

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.

Other names: Assessment of airway remodeling features on chest computed tomography, Assessment of remodelling in bronchial biopsy or bronchoalveolar lavage fluid

Primary outcomes

  1. assessment of the severity of epithelial damage and inflammation in the bronchial biopsy

    Time frame: 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.

  2. assessment of airway inflammation and remodeling in the airways in chest CT

    Time frame: 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.

  3. Assessment of biomarkers of inflammation in serum and BALF

    Time frame: baseline

    Assessment of cellular composition and inflammatory biomarkers in serum and BALF ( IL-2, IL4, IL-5, IL-8, PGE2, periostin, TSLP),

Study contacts

Contact information is provided by the study sponsor or research team.

Karolina Klimowicz, MD

CONTACT

[email protected]

+48 507045417

Marta Dabrowska, MD, PhD

CONTACT

[email protected]

+48 501157765

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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