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MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough

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ClinicalTrials.gov Identifier: NCT03363698
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Cough Cough Variant Asthma Upper-Airway Cough Syndrome GERD Allergic Rhinitis Other: Cough variant asthma treatment

Detailed Description:

The present study has the following objectives:

  1. to assess the prevalence of BHR in non-smoking adults with a chronic cough,
  2. to assess the prevalence of BHR in patients with UACS and GERD,
  3. to evaluate the relationship between BHR and cough reflex sensitivity,
  4. to assess the diagnostic accuracy of MCT in CVA with special regard to its discriminating value between CVA and other causes of a chronic cough, particularly GERD,
  5. to estimate prognostic value of BHR, fractional exhaled nitric oxide (FeNO) and induced sputum eosinophil count in predicting response to asthma treatment.

The investigated group will consist of 80 non-smoking adults (18-75 years old), who are not treated with angiotensin-converting enzyme inhibitors, with no signs of respiratory infection within six weeks prior to enrolment, with a normal chest radiograph and who are referred to the hospital due to a cough lasting at least eight weeks.

After obtaining an informed consent, the diagnostic approach of the most common causes of chronic cough will be performed: a medical history, physical examination, chest radiograph, in some cases chest computed tomography, pulmonary function tests (spirometry, fractional exhaled nitric oxide, methacholine challenge test), laboratory tests (total immunoglobulin E concentration, complete blood count), skin prick tests, induced sputum cell count, computed tomography of the paranasal sinuses and ENT consultation, 24-hour impedance with pH monitoring, videolaryngoscopy and cough challenge with capsaicin.

The cough severity will be assessed twice (on admission and after six weeks of causal treatment) using the Visual Analogue Scale (VAS), the Polish version of the Leicester Cough Questionnaire (LCQ) and the capsaicin inhalation cough challenge.

If MCT result is positive, CVA will be assumed the cause of a chronic cough and treatment with an inhaled steroid combined with a long-acting beta-agonist will be administered for at least 4 weeks. If no satisfactory response to this treatment is observed, an anti-leukotriene agent or in the next step systemic corticosteroid will be applied. Ineffective treatment with the above-mentioned medications will indicate an opportunity for a different underlying cause of BHR. The estimation the area under a ROC (receiver operating characteristic) curve will be used to determine the optimal cut-off point for the differentiation between asthma and alternate causes of a chronic cough.

It is expected to assess the frequency of bronchial hyperresponsiveness in subjects with a chronic cough, to confirm a correlation between the results of MCT and the sensitivity of cough reflex measured in capsaicin inhalation cough challenge. The investigation will probably determine a precise cut-off point for MCT which would allow discriminating asthma from other causes of a chronic cough.


Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Usefulness of the Methacholine Challenge Test and Capsaicin Inhalation Cough Challenge in a Prediction of Response to Management in Adults With a Chronic Cough.
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Cough
Drug Information available for: Capsaicin
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Cough variant asthma treatment
    Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.

Outcome Measures

Primary Outcome Measures :
  1. The decrease of a cough after cough variant asthma therapy measured by Leicester Cough Questionnaire (LCQ). [ Time Frame: at least 4 weeks of treatment ]
    Increase in quality of life measured with LCQ min. 1.3 points.

  2. The decrease of a cough after cough variant asthma therapy measured by Visual Analogue Scale (VAS). [ Time Frame: at least 4 weeks of treatment ]
    Reduction of cough intensity measured by VAS: Reduction min. 20 mm in VAS

  3. The decrease of a cough after cough variant asthma therapy measured by the cough challenge. [ Time Frame: at least 4 weeks of treatment ]
    Increase capsaicin concentration causing causing two/five (C2/C5) cough episode in the cough challenge.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-smoking patients aged 18-75, meeting inclusion criteria.
Criteria

Inclusion Criteria:

  1. Adults patients aged between 18 and 75;
  2. Chronic cough lasting more than 8 weeks;
  3. Non-smoking (min. 6 months);
  4. Not treated with angiotensin-converting enzyme (ACE) inhibitors;
  5. Not treated with:

    1. inhaled corticosteroids or systemic corticosteroids min. 4 weeks before enrolment,
    2. proton pump inhibitors min. 2 weeks before enrolment,
    3. antihistaminic drugs 1 week before enrolment;
  6. With normal chest radiograph or with insignificant changes in cough pathogenesis
  7. Without airway infection in previous 6 weeks.
  8. Patients enrolled with informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363698


Contacts
Contact: Aleksandra M. Rybka, MD +48 225992957 rybka.aleksandra@gmail.com

Locations
Poland
Department of Internal Medicine, Lung Diseases and Allergy Medical University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland, 02-097
Contact: Aleksandra M. Rybka, MD    +48 225992957    rybka.aleksandra@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
More Information

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03363698     History of Changes
Other Study ID Numbers: BHR in chronic cough
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
Chronic Cough
Upper-Airway Cough Syndrome
GERD
Allergic Rhinitis
Methacholine Challenge Test
Cough Challenge
Capsaicin

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Cough
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Capsaicin
Methacholine Chloride
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents