Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

January 22, 2009 updated by: AAADRS Clinical Research Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33134
        • AAADRS Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Nebulized budesonide
Drug: Nebulized Budesonide
Pulmicort Respules 0.5mg/2cc
Other Names:
  • Pulmicort Respules 0.5mg/2ml nebulized
Device: Nitric Oxide Analyzer
Niox NO analyzer
Other Names:
  • Niox NO analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exhaled breath nitric oxide pre- to post treatment
Time Frame: two weeks
two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Spirometry with peak flow measurements and daily diary scores
Time Frame: two weeks
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AAADRS Clinical Research Center

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Miguel J Lanz, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

January 23, 2009

Last Update Submitted That Met QC Criteria

January 22, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSBUPR-0062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Nebulized Budesonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe