Remodelling of the Lower Airways in Chronic Cough
Does Chronic Cough Lead to Injury and Remodelling of the Lower Airways?
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marta Dąbrowska, MD, PhD
- 전화번호: +48 501157765
- 이메일: mdabrowska@mp.pl
연구 연락처 백업
- 이름: Karolina Klimowicz, MD
- 전화번호: +48 507045417
- 이메일: mdabrowska@mp.pl
연구 장소
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Warsaw, 폴란드, 02-091
- 모병
- Medical University of Warsaw
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연락하다:
- Karolina Klimowicz, PhD candidate
- 전화번호: +48507045417
- 이메일: karolinaakrakowiak@gmail.com
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Warsaw, 폴란드, 02-097
- 모병
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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연락하다:
- Marta Dąbrowska
- 전화번호: 501157765
- 이메일: mdabrowska@mp.pl
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 02-097
- 모병
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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연락하다:
- Marta Dąbrowska, MD, PhD
- 전화번호: +48 501157765
- 이메일: mdabrowska@mp.pl
-
연락하다:
- Karolina Klimowicz, MD
- 전화번호: +48 507045417
- 이메일: karolinaakrakowiak@gmail.com
-
수석 연구원:
- Marta Dąbrowska, MD, PhD
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부수사관:
- Karolina Klimowicz, MD
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Warsaw
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Warsaw, Warsaw, 폴란드, 02-097
- 모병
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
-
연락하다:
- Karolina Klimowicz, MD
- 전화번호: +48 507045417
- 이메일: mdabrowska@mp.pl
-
수석 연구원:
- Marta Dąbrowska, MD, PhD
-
연락하다:
- Marta Dąbrowska
- 전화번호: +48 501157765
- 이메일: mdabrowska@mp.pl
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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 |
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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assessment of the severity of epithelial damage and inflammation in the bronchial biopsy
기간: baseline
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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.
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baseline
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assessment of airway inflammation and remodeling in the airways in chest CT
기간: baseline
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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.
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baseline
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Assessment of biomarkers of inflammation in serum and BALF
기간: baseline
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Assessment of cellular composition and inflammatory biomarkers in serum and BALF ( IL-2, IL4, IL-5, IL-8, PGE2, periostin, TSLP),
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baseline
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공동 작업자 및 조사자
수사관
- 연구 책임자: Rafał Krenke, MD, PhD, Prof, Department of Internal Medicine, Pulmonary Diseases and Allergy, Warsaw Medical University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Remodelling in CC
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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