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Trial record 15 of 1348 for:    cough

Montelukast for Postinfectious Cough

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ClinicalTrials.gov Identifier: NCT02352545
Recruitment Status : Unknown
Verified January 2015 by Liu Min, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Liu Min, 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
Cough Drug: Montelukast Phase 2

Detailed Description:
Patients in electrical treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Montelukast for Postinfectious Cough in Adults
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental: Montelukast
Patients in experimental 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.
Drug: Montelukast
Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .
Placebo Comparator: Placebo Comparator
Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,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. Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation [ Time Frame: 10 days ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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): NCT02352545


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

Locations
China, Beijing
Kewu Huang Recruiting
China, Beijing, China, 100190
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
Study Director: Kewu Huang, M.D. Beijing Chao Yang Hospital

Publications:

Responsible Party: Liu Min, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02352545     History of Changes
Other Study ID Numbers: Cough
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
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