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Montelukast for Postinfectious Cough

Montelukast for Postinfectious Cough in Adults

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02352545
Enrollment
200
Registered
2015-02-02
Start date
2014-08-31
Completion date
2015-10-31
Last updated
2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

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.

Interventions

DRUGMontelukast

Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation10 days

Secondary

MeasureTime frame
cough visual analogue scale scores post randomisation(area under the curve)10 days
Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation10 days

Countries

China

Contacts

Primary ContactKewu Huang, M.D.
kewuhuang@126.com86-10-85231167
Backup ContactMin Liu, Master
stream_1980@163.com86-0-13522226189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026