Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02655562
Recruitment Status : Unknown
Verified August 2016 by Mingming Jiang, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Mingming Jiang, Beijing Chao Yang Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Coughing Drug: Montelukast Phase 4

Detailed Description:

This project is a prospective, open label, randomized and controlled trial. All subacute cough patients that met the inclusion/exclusion criteria were recruited after signing the consent form. Patients were randomized into biomarker treatment armand standard treatment arm.

Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . 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.

Examine results of all patients from all arms were recorded before and after the 10 day treatment. The examine recorded are FENO levels, cough symptom assessment, cough visual assessment, Leicester cough questionnaire, total white blood cell count, neutrophil blood percentage, eosinophil blood percentage. Patient cough free days after treatment and Montelukast Sodium Tablets . Follow up was carried out at the 8th week after first record of symptom and 2 month after treatment.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: biomarker treatment arm
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).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
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.

Other Name: Placebo

Placebo Comparator: standard treatment arm
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.
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.

Other Name: Placebo




Primary Outcome Measures :
  1. Leicester cough questionnaire [ Time Frame: 10 days ]
    Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation


Secondary Outcome Measures :
  1. cough visual assessment [ Time Frame: 10 days ]
    Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • more than 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655562


Contacts
Layout table for location contacts
Contact: Mingming Jiang, Doctor 15350771390 jmmsh@sina.com
Contact: Kewu Huang, M.D. 86-10-85231167 kewuhuang@126.com

Locations
Layout table for location information
China
Mingming Jiang Recruiting
Beijing, China
Contact: Mingming Jiang         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Layout table for investigator information
Study Chair: Kewu Huang, M.D. Respiratory Medicine Department

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Mingming Jiang, Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02655562     History of Changes
Other Study ID Numbers: Beijing Chao Yang Hospital
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Nasal Decongestants
Montelukast
Bronchodilator Agents
Antitussive Agents
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents