Remodelling of the Lower Airways in Chronic Cough

NCT07659860 | Recruiting

• 1 other identifier: Remodelling in CC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chronic Cough

Keywords

remodelling; chronic cough

Outcome Measures

Primary Outcomes (3)

• assessment of the severity of epithelial damage and inflammation in the bronchial biopsy

  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

  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

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

  baseline

Study Arms (1)

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

Interventions

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.

Also known as: Assessment of airway remodeling features on chest computed tomography, Assessment of remodelling in bronchial biopsy or bronchoalveolar lavage fluid

40 patients with refractory chronic cough lasting more than 6 months.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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,
• cancer or interstitial lung disease,
• contraindications to functional testing, sputum induction or bronchoscopy

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (4)

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

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

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

Warsaw, Warsaw, 02-097, Poland

RECRUITING

Medical University of Warsaw

Warsaw, 02-091, Poland

RECRUITING

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

Warsaw, 02-097, Poland

RECRUITING

Related Publications (5)

• Chung KF, McGarvey L, Song WJ, Chang AB, Lai K, Canning BJ, Birring SS, Smith JA, Mazzone SB. Cough hypersensitivity and chronic cough. Nat Rev Dis Primers. 2022 Jun 30;8(1):45. doi: 10.1038/s41572-022-00370-w.

  PMID: 35773287 RESULT

• Macedo P, Zhang Q, Saito J, Liang Z, Ffolkes L, Nicholson AG, Chung KF. Analysis of bronchial biopsies in chronic cough. Respir Med. 2017 Jun;127:40-44. doi: 10.1016/j.rmed.2017.04.001. Epub 2017 Apr 4.

  PMID: 28502417 RESULT

• Gibson P, Wang G, McGarvey L, Vertigan AE, Altman KW, Birring SS; CHEST Expert Cough Panel. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016 Jan;149(1):27-44. doi: 10.1378/chest.15-1496. Epub 2016 Jan 6.

  PMID: 26426314 RESULT

• Dabrowska M, Grabczak EM, Arcimowicz M, Domeracka-Kolodziej A, Domagala-Kulawik J, Krenke R, Maskey-Warzechowska M, Tarchalska B, Chazan R. Causes of Chronic Cough in Non-smoking Patients. Adv Exp Med Biol. 2015;873:25-33. doi: 10.1007/5584_2015_153.

  PMID: 26285610 RESULT

• Irwin RS, French CL, Chang AB, Altman KW; CHEST Expert Cough Panel*. Classification of Cough as a Symptom in Adults and Management Algorithms: CHEST Guideline and Expert Panel Report. Chest. 2018 Jan;153(1):196-209. doi: 10.1016/j.chest.2017.10.016. Epub 2017 Nov 10.

  PMID: 29080708 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood bronchoalveolat lavage fluid bronchial biopsy

MeSH Terms

Conditions

Chronic Cough

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Rafał Krenke, MD, PhD, Prof

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

  STUDY DIRECTOR

Central Study Contacts

Marta Dabrowska, MD, PhD

CONTACT

+48 501157765; mdabrowska@mp.pl

Karolina Klimowicz, MD

CONTACT

+48 507045417; mdabrowska@mp.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: October 1, 2022
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

PL (4)