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

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ClinicalTrials.gov Identifier: NCT02303600
Recruitment Status : Unknown
Verified November 2014 by Min Liu, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Min Liu, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Coughing Drug: Montelukast Other: Placebo Not Applicable

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 arm and standard treatment arm. Positive or negative biomarker expression was confirmed by assessing fractional concentration of exhaled NO (FENO) level, FENO<25ppb was regarded as negative and FENO≥25ppb was regarded as positive.

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(p.o., 10mg, q.d.). 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.

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.

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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 Montelukast Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

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

Active Comparator: standard treatment arm
Patients in standard treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .
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.




Primary Outcome Measures :
  1. Leicester cough questionnaire [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. cough visual assessment [ Time Frame: 10 days ]


Information from the National Library of Medicine

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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
  • ≥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 rhinallergosis, 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): NCT02303600


Contacts
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Contact: Kewu Huang, M.D. 86-10-85231167 kewuhuang@126.com
Contact: Min Liu, Master 86-0-13522226189 stream_1980@163.com

Locations
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China, Beijing
Beijing Chaoyang Hospital affiliated to Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Kewu Huang, M.D.    86-10-85231167    kewuhuang@126.com   
Contact: Min Liu, Master    86-0-13522226189    stream_1980@163.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Study Chair: Kewu Huang, M.D. Beijing Chao Yang Hospital
Publications:

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Responsible Party: Min Liu, resident, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02303600    
Other Study ID Numbers: SAC2014
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: December 1, 2014
Last Verified: November 2014
Keywords provided by Min Liu, Beijing Chao Yang Hospital:
Sub-acute cough
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Montelukast
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