Coughing Clinical Trial
Official title:
Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
Verified date | July 2022 |
Source | Beijing Chao Yang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute cough refers to a cough of 3-8-week duration, and is typically refractory to standard anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials have evaluated therapeutic options for subacute cough. Airway inflammation is an important feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl leukotrienes increase in virus infection. Airway inflammation induce epithelial cells produce iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast is a cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16 and reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid dose, But A meta-analysis of the effectiveness of LTRA( leukotriene receptor antagonist,LTRA)in treating children with prolonged non-specific cough concluded that, with the lack of evidence, the routine use of LTRA in treating children with non-specific cough cannot be recommended. A randomised, placebo-controlled trial showed montelukast is not an effective treatment for postinfectious cough. Non-specialists or general practitioners of Japan prescribe LTRA very often, which increase. The aim is to research whether FeNO can be used as a biomarker to direct montelukast treatment and optimize treatment regimen of sub-acute cough.
Status | Suspended |
Enrollment | 200 |
Est. completion date | February 2026 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes - more than 18 year old, regardless of gender and ethical background - Not taking angiotensin-converting enzyme inhibitor - Patients must join the programme voluntarily and are able to attend examination and follow-up sessions Exclusion Criteria: - Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections - Patients diagnosed with severe reportorial disease of other severe systemic disease - Patients who are allergic to any drugs to be tested - Patients who are non-cooperative during examination sessions or other steps of the trial - Patients who are not able to or refuse to sign consent |
Country | Name | City | State |
---|---|---|---|
China | Mingming Jiang | Beijing |
Lead Sponsor | Collaborator |
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Beijing Chao Yang Hospital |
China,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leicester cough questionnaire | Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation | 10 days | |
Secondary | cough visual assessment | Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation | 10 days |
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