Overview

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

Status:
Unknown status

Trial end date:
2011-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Guangzhou Medical University

Treatments:

Budesonide
Montelukast

Criteria

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