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Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

NCT01404013 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2014-07-14

No results posted yet for this study

Summary

This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).

The investigators hypothesize:

1. Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
2. Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.

Conditions

Interventions

DRUG

ICS/LABA

Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks

DRUG

Montelukast

Montelukast 10mg ,every night, for 8 weeks

DRUG

ICS/LABA and Montelukast

Budesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Mengfeng Li, MD. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404013 on ClinicalTrials.gov