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

University Hospital Ostrava

Status: Enrolling

Conditions: Asthma; Laryngopharyngeal Reflux; Extraesophageal Reflux; Allergy; Chronic Cough

Treatments: Behavioral: Lifestyle modifications and Antireflux diet; Diagnostic Test: Extraesophageal reflux diagnostic

Study type: Interventional

Funder types: Other

Identifiers

NCT04984304

FNO-ENT-EER_Cough

Details and patient eligibility

About

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).

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Mild cough

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle modifications and Antireflux diet

Moderate and severe cough

Experimental group

Description:

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

Treatment:

Diagnostic Test: Extraesophageal reflux diagnostic