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

NCT04984304 | Unknown

• 1 other identifier: FNO-ENT-EER_Cough
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

chronic cough; extraesophageal reflux; laryngopharyngeal reflux; allergy; asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• Diet and life-style modifications and asthma

  6 months

• Allergic diseases and chronic cough with concomitant extraesophageal reflux

  6 months

• Individual phenotypes of bronchial asthma in patients with EER

  6 months

• Asthma severity and control

  6 months

Study Arms (2)

Mild cough

EXPERIMENTAL

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

Behavioral: Lifestyle modifications and Antireflux diet

Moderate and severe cough

EXPERIMENTAL

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

Diagnostic Test: Extraesophageal reflux diagnostic

Interventions

Lifestyle modifications and Antireflux diet 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.

Mild cough

Extraesophageal reflux diagnostic 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

Moderate and severe cough

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• patients with chronic cough (cough that lasts 3 months or longer)
• consent with participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (4)

• 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.

  PMID: 27614002 BACKGROUND

• 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.

  PMID: 31182314 BACKGROUND

• 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.

  PMID: 25605530 BACKGROUND

• 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.

  PMID: 28298354 BACKGROUND

MeSH Terms

Conditions

Chronic Cough; Laryngopharyngeal Reflux; Hypersensitivity; Asthma

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Viktória Hránková, MD,PhD,FESO

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 30, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)