Montelukast for Postinfectious Cough

January 28, 2015 updated by: Liu Min, Beijing Chao Yang Hospital

Montelukast for Postinfectious Cough in Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • China, Beijing, China, 100190
        • Recruiting
        • Kewu Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
Time Frame: 10 days
10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2015

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cough

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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