Remodelling of the Lower Airways in Chronic Cough
Does Chronic Cough Lead to Injury and Remodelling of the Lower Airways?
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Marta Dąbrowska, MD, PhD
- 電話番号：+48 501157765
- メール：mdabrowska@mp.pl
研究連絡先のバックアップ
- 名前：Karolina Klimowicz, MD
- 電話番号：+48 507045417
- メール：mdabrowska@mp.pl
研究場所
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Warsaw、ポーランド、02-091
- 募集
- Medical University of Warsaw
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コンタクト：
- Karolina Klimowicz, PhD candidate
- 電話番号：+48507045417
- メール：karolinaakrakowiak@gmail.com
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Warsaw、ポーランド、02-097
- 募集
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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コンタクト：
- Marta Dąbrowska
- 電話番号：501157765
- メール：mdabrowska@mp.pl
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Masovian Voivodeship
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Warsaw、Masovian Voivodeship、ポーランド、02-097
- 募集
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
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コンタクト：
- Marta Dąbrowska, MD, PhD
- 電話番号：+48 501157765
- メール：mdabrowska@mp.pl
-
コンタクト：
- Karolina Klimowicz, MD
- 電話番号：+48 507045417
- メール：karolinaakrakowiak@gmail.com
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主任研究者：
- Marta Dąbrowska, MD, PhD
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副調査官：
- Karolina Klimowicz, MD
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Warsaw
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Warsaw、Warsaw、ポーランド、02-097
- 募集
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
-
コンタクト：
- Karolina Klimowicz, MD
- 電話番号：+48 507045417
- メール：mdabrowska@mp.pl
-
主任研究者：
- Marta Dąbrowska, MD, PhD
-
コンタクト：
- Marta Dąbrowska
- 電話番号：+48 501157765
- メール：mdabrowska@mp.pl
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
assessment of the severity of epithelial damage and inflammation in the bronchial biopsy
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Rafał Krenke, MD, PhD, Prof、Department of Internal Medicine, Pulmonary Diseases and Allergy, Warsaw Medical University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
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