NCT00110383

Brief Summary

  1. 1.Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
  2. 2.Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.
  3. 3.Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
  4. 4.Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2004

Typical duration for not_applicable asthma

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

May 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 6, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 4, 2014

Status Verified

December 1, 2007

First QC Date

May 6, 2005

Last Update Submit

March 2, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Asthma exacerbations

    Measured at 15 months

Study Arms (2)

1

EXPERIMENTAL

Supervised therapy

Behavioral: School-Based Supervised Asthma Therapy

2

NO INTERVENTION

Inhaled steroid use as usual care

Interventions

School-Based Supervised Asthma TherapyBEHAVIORAL

Child's inhaled steroid use supervised daily at school

1

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Persistent asthma requiring daily controller medication
  • Enrolled at a participating elementary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Birmingham Lung Health Center

Birmingham, Alabama, 35233-7337, United States

Location

Related Publications (1)

  • Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.

    PMID: 19017893DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lynn B. Gerald, PhD, MSPH

    University of Alabama Birmingham Lung Health Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2005

First Posted

May 9, 2005

Study Start

May 1, 2004

Study Completion

May 1, 2007

Last Updated

March 4, 2014

Record last verified: 2007-12

Locations

US(1)