NCT02655562

Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough：A Prospective, Open Label, Randomized and Placebo-Controlled Trial

Suspended Phase 4 Last updated 20 July 2022

What this trial tests

Phase 4 trial testing Montelukast in Coughing in 200 participants. Suspended.

Timeline

1 April 2016

Primary endpoint
1 December 2024

1 February 2026

Quick facts

Lead sponsor	Beijing Chao Yang Hospital
Phase	Phase 4
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 April 2016
Primary completion	1 December 2024
Estimated completion	1 February 2026
Sites	1 location across China

Drugs / interventions tested

• Montelukast (montelukast) — full drug profile →

Conditions studied

• Coughing — all drugs for Coughing →

Sponsor

Beijing Chao Yang Hospital

Who can join

18 and older, any sex, with Coughing. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Leicester cough questionnaire
  Time frame: 10 days
  Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.