Remodelling of the Lower Airways in Chronic Cough
ConditionChronic Cough
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedical University of Warsaw
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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,
Trial population
In 30 patients referred to the cough clinic for refractory chronic cough lasting more than 6 months
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
chest computed tomography and bronchoscopy
Diagnostic testAssessment 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: 40 patients with refractory chronic cough lasting more than 6 months.1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline2
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.
Time frame
baseline3
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),
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov