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Completed

NCT Number: NCT00522782

Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AAADRS Clinical Research Center

Coral Gables, Florida, 33134, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized Budesonide

Drug

Pulmicort Respules 0.5mg/2cc

Other names: Pulmicort Respules 0.5mg/2ml nebulized

Nitric Oxide Analyzer

Device

Niox NO analyzer

Other names: Niox NO analyzer

Primary outcomes

  1. Exhaled breath nitric oxide pre- to post treatment

    Time frame: two weeks

Secondary outcomes

  1. Spirometry with peak flow measurements and daily diary scores

    Time frame: two weeks

Sponsors and collaborators

Lead sponsor

AAADRS Clinical Research Center

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Aug 30, 2007
Registry last updated
Jan 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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