Clinical trial NCT04984304: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Cough
Extraesophageal Reflux
Laryngopharyngeal Reflux
Allergy
Asthma
Keywords: chronic cough
extraesophageal reflux
laryngopharyngeal reflux
allergy
asthma
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: EER severity and type and allergy
timeFrame: 6 months
Secondary outcomes:
measure: Diet and life-style modifications and asthma
timeFrame: 6 months
measure: Allergic diseases and chronic cough with concomitant extraesophageal reflux
timeFrame: 6 months
measure: Individual phenotypes of bronchial asthma in patients with EER
timeFrame: 6 months
measure: Asthma severity and control
timeFrame: 6 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Viktória Hránková, MD,PhD,FESO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.