MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough

NCT03363698 | Completed

• 1 other identifier: BHR in chronic cough
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the prevalence of bronchial hyperresponsiveness (BHR) in non-smoking adults with chronic cough and the prevalence of BHR in patients with upper airway cough syndrome (UACS) and gastroesophageal reflux disease (GERD), to evaluate the relationship between BHR and cough reflex sensitivity, to assess the diagnostic accuracy of methacholine challenge test (MCT) in cough variant asthma (CVA) with special regard to its discriminating cut off value between CVA and other causes of chronic cough, particularly GERD, to estimate prognostic value of BHR, fractional exhaled nitric oxide (FeNO) and induced sputum eosinophil count in predicting response to asthma treatment. Patients diagnosed with a chronic cough will undergo the standard diagnostic work-up recommended by experts for patients with a chronic cough, including methacholine challenge test (MCT) and an at least 4-week period of causal treatment. Patients with BHR in MCT will be treated with - in first step B2-agonist and inhaled corticosteroid (ICS) for at least 4 weeks, if improvement is not significant in next steps with leukotriene receptor antagonist (LTRA) or systemic corticosteroid. A good treatment response, evaluated by visual analogue scale (VAS), Leicester Cough Questionnaire (LCQ) and cough challenge will confirm the diagnosis of the disease. A statistical analysis will consist of the frequency of BHR in a chronic cough, correlation between the results of MCT and cough reflex sensitivity in capsaicin inhalation test and cut-off point for MCT to discriminate asthma from other causes of a chronic cough.

Conditions

Cough; Cough Variant Asthma; Upper-Airway Cough Syndrome; GERD; Allergic Rhinitis

Keywords

Chronic Cough; Upper-Airway Cough Syndrome; GERD; Allergic Rhinitis; Methacholine Challenge Test; Cough Challenge; Capsaicin

Outcome Measures

Primary Outcomes (3)

• The decrease of a cough after cough variant asthma therapy measured by Leicester Cough Questionnaire (LCQ).

  Increase in quality of life measured with LCQ min. 1.3 points.

  at least 4 weeks of treatment

• The decrease of a cough after cough variant asthma therapy measured by Visual Analogue Scale (VAS).

  Reduction of cough intensity measured by VAS: Reduction min. 20 mm in VAS

  at least 4 weeks of treatment

• The decrease of a cough after cough variant asthma therapy measured by the cough challenge.

  Increase capsaicin concentration causing causing two/five (C2/C5) cough episode in the cough challenge.

  at least 4 weeks of treatment

Interventions

Cough variant asthma treatment OTHER

Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-smoking patients aged 18-75, meeting inclusion criteria.

You may qualify if:

• Adults patients aged between 18 and 75;
• Chronic cough lasting more than 8 weeks;
• Non-smoking (min. 6 months);
• Not treated with angiotensin-converting enzyme (ACE) inhibitors;
• Not treated with:
• inhaled corticosteroids or systemic corticosteroids min. 4 weeks before enrolment,
• proton pump inhibitors min. 2 weeks before enrolment,
• antihistaminic drugs 1 week before enrolment;
• With normal chest radiograph or with insignificant changes in cough pathogenesis
• Without airway infection in previous 6 weeks.
• Patients enrolled with informed consent.

You may not qualify if:

• Patients under 18 years old and above 75 years old;
• Smokers (actual or ex-smokers shorter than 6 weeks);
• Therapy with corticosteroids (inhaled or systemic) for last 4 weeks, proton pump inhibitors for 2 weeks, antihistaminic drug for 1 week before enrolment;
• Airway infection 6 weeks preceding enrolment or during study - re-attempt to enroll after 6 weeks

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine, Lung Diseases and Allergy Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Cough; Cough-Variant Asthma; upper airway cough syndrome; Gastroesophageal Reflux; Rhinitis, Allergic; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 6, 2017
• Study Start: December 31, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)