Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

AAADRS Clinical Research Center16 enrolled

Overview

To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.

Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Nebulized BudesonideDRUG

Pulmicort Respules 0.5mg/2cc

Nitric Oxide AnalyzerDEVICE

Niox NO analyzer

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Asthma diagnosis previously for 6 months * Past asthma medication without change for previous 6 months * Increased NO levels and ability to perform maneuver * ICF signed by parents Exclusion Criteria: * Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks * Hospitalization within 3 months * Upper or lower airways active infection or cigarette smoke direct exposure * Use of other asthma medications other than bronchodilators one month prior and during the trial * Noncompliance

Locations (1)

AAADRS Clinical Research Center

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Exhaled breath nitric oxide pre- to post treatment

Time frame: two weeks

Secondary Outcomes

Spirometry with peak flow measurements and daily diary scores

Time frame: two weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.