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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
assessment of the severity of epithelial damage and inflammation in the bronchial biopsy — 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.
assessment of airway inflammation and remodeling in the airways in chest CT — 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.
Assessment of biomarkers of inflammation in serum and BALF — baseline Assessment of cellular composition and inflammatory biomarkers in serum and BALF ( IL-2, IL4, IL-5, IL-8, PGE2, periostin, TSLP),
Trial sites (4)
Facility
City
Region
Status
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
Warsaw
Masovian Voivodeship
Recruiting
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
Warsaw
Warsaw
Recruiting
Medical University of Warsaw
Warsaw
Poland
Recruiting
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
Warsaw
Poland
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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