Clinical trial NCT02352545: Montelukast for Postinfectious Cough
Official title: Montelukast for Postinfectious Cough in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cough
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3\~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.

Detailed description: Patients in electrical treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.

Eligibility criteria: 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

  * 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

Primary outcomes:
measure: Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
timeFrame: 10 days
Secondary outcomes:
measure: cough visual analogue scale scores post randomisation(area under the curve)
timeFrame: 10 days
measure: Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation
timeFrame: 10 days
Other outcomes:
Locations:
city: China
country: China
facility: Kewu Huang
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Kewu Huang, M.D.
role: STUDY_DIRECTOR
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