CoughNCT03363698
MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough
An observational study of Cough and Cough Variant Asthma, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough, Cough Variant Asthma, Upper-Airway Cough Syndrome
- What is being tested?
- Cough variant asthma treatment
- How many people
- 55 participants
- Where
- 1 sitePoland
- Study dates
- 31 Dec 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-smoking patients aged 18-75, meeting inclusion criteria.
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine, Lung Diseases and Allergy Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
About this study
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.
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.
Read the detailed description
The present study has the following objectives:
- to assess the prevalence of BHR in non-smoking adults with a chronic cough,
- to assess the prevalence of BHR in patients with UACS and GERD,
- to evaluate the relationship between BHR and cough reflex sensitivity,
- 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,
- 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.
- Being tested
- Cough variant asthma treatment
- Keywords
- Chronic Cough, Upper-Airway Cough Syndrome, GERD, Allergic Rhinitis, Methacholine Challenge Test, Cough Challenge, Capsaicin
- Medical subject headings
- Cough, Cough-Variant Asthma, upper airway cough syndrome, Gastroesophageal Reflux, Rhinitis, Allergic, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough variant asthma treatmentOther
Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: at least 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start31 Dec 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363698
- Sponsor's protocol ID
- BHR in chronic cough
- Status last verified
- Jun 2021
- First submitted
- 8 Nov 2017
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03363698
- Acronym / sponsor ID
- BHR in chronic cough
- Keywords
- Chronic Cough, Upper-Airway Cough Syndrome, GERD, Allergic Rhinitis, Methacholine Challenge Test, Cough Challenge, Capsaicin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study has the following objectives:
- to assess the prevalence of BHR in non-smoking adults with a chronic cough,
- to assess the prevalence of BHR in patients with UACS and GERD,
- to evaluate the relationship between BHR and cough reflex sensitivity,
- 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,
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-smoking patients aged 18-75, meeting inclusion criteria.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough variant asthma treatmentEvaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone. | Other | – |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Cough Variant Asthma, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease of a cough after cough variant asthma therapy measured by Leicester Cough Questionnaire (LCQ). (time frame: at least 4 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.