Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-05-31

Brief Summary

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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).

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Detailed Description

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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). 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

Conditions

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Chronic Cough Extraesophageal Reflux Laryngopharyngeal Reflux Allergy Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild cough

Mild cough only slightly worsening the quality of life (VAS 1-3)

Group Type EXPERIMENTAL

Lifestyle modifications and Antireflux diet

Intervention Type 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.

Moderate and severe cough

Moderate and severe cough that significantly worsen the quality of life (VAS 4-10)

Group Type EXPERIMENTAL

Extraesophageal reflux diagnostic

Intervention Type 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

Interventions

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Lifestyle modifications and Antireflux diet

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 BEHAVIORAL

Extraesophageal reflux diagnostic

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No