An observational study in Cough, Cough Variant Asthma and Upper-Airway Cough Syndrome, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Medical University of Warsaw · Observational
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.
The present study has the following objectives:
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.
142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 37 observational studies indexed under Chronic Cough.
Browse Chronic Cough studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Compared within Chronic Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cough. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Non-smoking patients aged 18-75, meeting inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Not treated with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.
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.
Time frame: 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
Time frame: 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.
Time frame: at least 4 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Dec 2020, 0 months.
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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