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Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough

NCT02303600 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-12-01

No results posted yet for this study

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.

Conditions

  • Coughing

Interventions

DRUG

Montelukast

Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.). Patients in biomarker guided negative treatment arm were given placebo tablets . Patients in standard treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.

OTHER

Placebo

Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate) (p.o., 10mg, q.d.) .

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    lead OTHER

Principal Investigators

  • Kewu Huang, M.D. · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303600 on ClinicalTrials.gov