Remodelling of the Lower Airways in Chronic Cough

June 15, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marta Dąbrowska, MD, PhD
  • Phone Number: +48 501157765
  • Email: mdabrowska@mp.pl

Study Contact Backup

  • Name: Karolina Klimowicz, MD
  • Phone Number: +48 507045417
  • Email: mdabrowska@mp.pl

Study Locations

  • Poland
      • Warsaw, Poland, 02-091
        • Recruiting
        • Medical University of Warsaw
        • Contact:
      • Warsaw, Poland, 02-097
        • Recruiting
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Contact:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Recruiting
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Dąbrowska, MD, PhD
        • Sub-Investigator:
          • Karolina Klimowicz, MD
    • Warsaw
      • Warsaw, Warsaw, Poland, 02-097
        • Recruiting
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
        • Contact:
        • Principal Investigator:
          • Marta Dąbrowska, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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),
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Remodelling in CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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