NCT00522782

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 23, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

August 28, 2007

Last Update Submit

January 22, 2009

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Exhaled breath nitric oxide pre- to post treatment

    two weeks

Secondary Outcomes (1)

  • Spirometry with peak flow measurements and daily diary scores

    two weeks

Study Arms (1)

A

ACTIVE COMPARATOR

Nebulized budesonide

Drug: Nebulized BudesonideDevice: Nitric Oxide Analyzer

Interventions

Nebulized BudesonideDRUG

Pulmicort Respules 0.5mg/2cc

Also known as: Pulmicort Respules 0.5mg/2ml nebulized
A
Nitric Oxide AnalyzerDEVICE

Niox NO analyzer

Also known as: Niox NO analyzer
A

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AAADRS Clinical Research Center

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Miguel J Lanz, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

January 23, 2009

Record last verified: 2009-01

Locations

US(1)