Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Primary Purpose
Chronic Cough, Extraesophageal Reflux, Laryngopharyngeal Reflux
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Lifestyle modifications and Antireflux diet
Extraesophageal reflux diagnostic
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cough focused on measuring chronic cough, extraesophageal reflux, laryngopharyngeal reflux, allergy, asthma
Eligibility Criteria
Inclusion Criteria:
- age 18-80 years
- patients with chronic cough (cough that lasts 3 months or longer)
- consent with participation in the study
Exclusion Criteria:
- patients using ACE inhibitors or Angiotensin II receptor blockers
- patients with head and neck cancer
- patients after radiotherapy in the head and neck area
- patients with airway or lung cancer
- patients with chronic lung disease except for bronchial asthma (COPD, interstitial lung disease, bronchiectasis, respiratory bronchiolitis)
- patients with chronic rhinosinusitis
Sites / Locations
- University Hospital OstravaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mild cough
Moderate and severe cough
Arm Description
Mild cough only slightly worsening the quality of life (VAS 1-3)
Moderate and severe cough that significantly worsen the quality of life (VAS 4-10)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT04984304
First Posted
June 1, 2021
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT04984304
Brief Title
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Official Title
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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
signing of Informed Consent
anamnestic questionnaire (age, sex, weight, height, smoking, alcohol, reflux disease, treatment of allergic disease, pyrosis, treatment of reflux disease)
Allergology examination
Cough Visual Analogue Scale (VAS)
Hull Airway Reflux Questionnaire
Asthma Control Test
Spirometry
Prick Tests
Fractional Exhaled nitric oxide (FeNO) test
Laboratory tests (IgE, specific IgE, ECP)
Otorhinolaryngologic examination
Cough Visual Analogue Scale (VAS)
RSS -12 (Reflux Symptom Score - 12)
RSA - Short version (Reflux Sign Assessment - Short version)
The Perceived Stress Scale
Evaluation of Compliance with Antireflux Precaution Visual Analogue Scale (VAS)
dividing patients into 2 arms
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
Esophageal 24-hour pH/Impedance Reflux Monitoring
Peptest study on fasting
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough, Extraesophageal Reflux, Laryngopharyngeal Reflux, Allergy, Asthma
Keywords
chronic cough, extraesophageal reflux, laryngopharyngeal reflux, allergy, asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild cough
Arm Type
Experimental
Arm Description
Mild cough only slightly worsening the quality of life (VAS 1-3)
Arm Title
Moderate and severe cough
Arm Type
Experimental
Arm Description
Moderate and severe cough that significantly worsen the quality of life (VAS 4-10)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modifications and Antireflux diet
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Extraesophageal reflux diagnostic
Intervention Description
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
Primary Outcome Measure Information:
Title
EER severity and type and allergy
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diet and life-style modifications and asthma
Description
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.
Time Frame
6 months
Title
Allergic diseases and chronic cough with concomitant extraesophageal reflux
Description
Comparison of the frequency of individual allergic diseases in patients with chronic cough and concomitant extraesophageal reflux.
Time Frame
6 months
Title
Individual phenotypes of bronchial asthma in patients with EER
Description
Comparison of the frequency of individual phenotypes of bronchial asthma in patients with proven extraesophageal reflux.
Time Frame
6 months
Title
Asthma severity and control
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-80 years
patients with chronic cough (cough that lasts 3 months or longer)
consent with participation in the study
Exclusion Criteria:
patients using ACE inhibitors or Angiotensin II receptor blockers
patients with head and neck cancer
patients after radiotherapy in the head and neck area
patients with airway or lung cancer
patients with chronic lung disease except for bronchial asthma (COPD, interstitial lung disease, bronchiectasis, respiratory bronchiolitis)
patients with chronic rhinosinusitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktória Hránková, MD,PhD,FESO
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Viktória Hránková, MD
First Name & Middle Initial & Last Name & Degree
Martin Formánek, MD,PhD
First Name & Middle Initial & Last Name & Degree
Karol Zeleník, Assoc.Prof.,MD,PhD,MBA
First Name & Middle Initial & Last Name & Degree
Tomáš Balner, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27614002
Citation
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.
Results Reference
background
PubMed Identifier
31182314
Citation
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.
Results Reference
background
PubMed Identifier
25605530
Citation
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.
Results Reference
background
PubMed Identifier
28298354
Citation
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.
Results Reference
background
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Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
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