UnknownPhase 4

Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis

China63 participantsStarted 2010-06

Plain-language summary

Hypothesis: Add-on therapy with oral montelukast (Mon) to inhaled budesonide (BUD) may achieve better control of cough caused by nonasthmatic eosinophilic bronchitis (NAEB) with faster reduction of airway eosinophilia. Objective: To evaluate the efficacy of add-on therapy with Mon to inhaled corticosteroids (ICS) in the treatment of adult patients with chronic/subacute cough caused by NAEB diagnosed in outpatient setting. Primary endpoint：cough severity rated as cough visual analogue score (VAS)1 and eosinophil count in induced sputum during 4-week BUD monotherapy or Mon adjunct therapy.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult nonsmoking NAEB patients * Without history of taking Mon, oral or inhaled corticosteroids, and * Without bacterial or viral respiratory infections within 30 days prior to diagnosis of NAEB Exclusion Criteria: * Current smokers * Pregnant or lactating women * Known allergy to Mon, oral or inhaled corticosteroids * Unable to use ICS following repeated instructions * Complicated with unresectable malignancy or severe heart, lung, liver or kidney diseases

What they're measuring

cough severity rated as cough visual analogue score (VAS)

Timeframe: 4 weeks

eosinophil count in induced sputum

Timeframe: 4 weeks

Trial details

NCT IDNCT01121016

SponsorGuangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

Contact for this trial

Chuang Cai, Ph.D

862083062844 skinblack1966@yahoo.com.cn

View on ClinicalTrials.gov More Nonasthmatic Eosinophilic Bronchitis trials