Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 6:37 PM
Study NCT ID:
NCT04984304
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2021-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Sponsor:
University Hospital Ostrava
Organization:
Study Overview
Official Title:
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: