Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

AAADRS Clinical Research Center

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Nebulized Budesonide; Device: Nitric Oxide Analyzer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00522782

IRUSBUPR-0062

Details and patient eligibility

About

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.

Full description

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

Enrollment: 16 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

A

Active Comparator group

Description:

Nebulized budesonide

Treatment:

Device: Nitric Oxide Analyzer

Drug: Nebulized Budesonide