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Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER).
The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it).
Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER). Liquid reflux, or even just aerosol reflux, causes mucosal inflammation and sensitizes the mucous membrane of the airways, which is then sensitive to even slight noxa. The cough then further damages the mucosa, creating a vicious circle. EER can be the main cause of chronic cough, but also a worsening cofactor of cough in patients with other causes (allergic and non-allergic bronchial asthma, chronic rhinosinusitis, and others).
The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it). Accurate diagnosis and assessment of severity allow patients to be divided into 2 groups. The group with mild symptoms and the findings will be treated in the first phase with diet and lifestyle modifications. With a positive response to this "conservative" type of treatment, patients would not have to undergo a series of tests. Patients with severe problems and confirmed EER will be treated individually according to recommended measures.
Study protocol
Allergology examination
Otorhinolaryngologic examination
Arm 1 - mild cough only slightly worsening the quality of life (VAS 1-3) - treatment using lifestyle modifications and Antireflux diet for 3 months. In case of persistent severity of cough or worsening - continue to Arm 2 Arm 2 - moderate and severe cough that significantly worsen the quality of life (VAS 4-10)
Extraesophageal reflux diagnostic
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild cough | Experimental | Mild cough only slightly worsening the quality of life (VAS 1-3) |
|
| Moderate and severe cough | Experimental | Moderate and severe cough that significantly worsen the quality of life (VAS 4-10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle modifications and Antireflux diet | Behavioral | Patients in Arm 1 - mild cough only slightly worsening the quality of life (VAS 1-3) will undergo treatment using lifestyle modifications and an Antireflux diet for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| EER severity and type and allergy | Comparison of extraesophageal reflux severity and type in patients with chronic cough with or without concomitant allergic cause of cough. The number of EER events on impedance and improvement of RSA - Short version scale (Reflux Sign Assessment - Short version) will be observed and compared with improvement of objective measurements and clinical findings. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diet and life-style modifications and asthma | Evaluation of the importance of diet and life-style modifications in patients with mild symptoms findings of extraesophageal reflux in patients with concomitant bronchial asthma and without concomitant bronchial asthma. The percentage of recommended diet compliance will be compared with the scores of improvement of RSA - Short version scale (Reflux Sign Assessment - Short version) and clinical findings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Viktória Hránková, MD,PhD,FESO | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27614002 | Background | Kahrilas PJ, Altman KW, Chang AB, Field SK, Harding SM, Lane AP, Lim K, McGarvey L, Smith J, Irwin RS; CHEST Expert Cough Panel. Chronic Cough Due to Gastroesophageal Reflux in Adults: CHEST Guideline and Expert Panel Report. Chest. 2016 Dec;150(6):1341-1360. doi: 10.1016/j.chest.2016.08.1458. Epub 2016 Sep 7. | |
| 31182314 | Background |
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| Extraesophageal reflux diagnostic | Diagnostic Test | Patients in Arm 2 - moderate and severe cough that significantly worsen the quality of life (VAS 4-10) will undergo extraesophageal reflux diagnostics consisting of esophageal 24-hour pH/Impedance Reflux Monitoring and peptest study on fasting |
|
| 6 months |
| Allergic diseases and chronic cough with concomitant extraesophageal reflux | Comparison of the frequency of individual allergic diseases in patients with chronic cough and concomitant extraesophageal reflux. | 6 months |
| Individual phenotypes of bronchial asthma in patients with EER | Comparison of the frequency of individual phenotypes of bronchial asthma in patients with proven extraesophageal reflux. | 6 months |
| Asthma severity and control | Evaluation of the evolution of asthma severity and the level of asthma control in patients with bronchial asthma and extraesophageal reflux while following a diet and life-style modifications. The percentage of recommended diet compliance will be correlated with the possibility to discontinue administration of selected drugs (e.g. corticosteroids and biological treatment). | 6 months |
| Kanemitsu Y, Kurokawa R, Takeda N, Takemura M, Fukumitsu K, Asano T, Yap J, Suzuki M, Fukuda S, Ohkubo H, Maeno K, Ito Y, Oguri T, Niimi A. Clinical impact of gastroesophageal reflux disease in patients with subacute/chronic cough. Allergol Int. 2019 Oct;68(4):478-485. doi: 10.1016/j.alit.2019.04.011. Epub 2019 Jun 7. |
| 25605530 | Background | Shirai T, Mikamo M, Tsuchiya T, Shishido Y, Akita T, Morita S, Asada K, Fujii M, Suda T. Real-world effect of gastroesophageal reflux disease on cough-related quality of life and disease status in asthma and COPD. Allergol Int. 2015 Jan;64(1):79-83. doi: 10.1016/j.alit.2014.08.001. Epub 2014 Oct 22. |
| 28298354 | Background | Herregods TVK, Pauwels A, Jafari J, Sifrim D, Bredenoord AJ, Tack J, Smout AJPM. Determinants of reflux-induced chronic cough. Gut. 2017 Dec;66(12):2057-2062. doi: 10.1136/gutjnl-2017-313721. Epub 2017 Mar 15. |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D057045 | Laryngopharyngeal Reflux |
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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