Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

Asthma Clinical Trial

Official title:

Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522782
• Other study ID #: IRUSBUPR-0062
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2007
• Last updated: January 22, 2009
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: AAADRS Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Nebulized Budesonide
Pulmicort Respules 0.5mg/2cc

Device:
• Nitric Oxide Analyzer
Niox NO analyzer

Locations

Country	Name	City	State
United States	AAADRS Clinical Research Center	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AAADRS Clinical Research Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled breath nitric oxide pre- to post treatment		two weeks
Secondary	Spirometry with peak flow measurements and daily diary scores		two weeks