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Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough

NCT02655562 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Coughing

Interventions

DRUG

Montelukast

Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO\<25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO\<25ppb 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.

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    lead OTHER

Principal Investigators

  • Kewu Huang, M.D. · Respiratory Medicine Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2024-12-31
Completion
2026-02-28

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 NCT02655562 on ClinicalTrials.gov