NCT00204841

Brief Summary

Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or events repetitively emerge for their ability to significantly influence asthma inception in the first decade of life: immune response aberrations, which appear to be defined best by the concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV); and some form of gene by environment interaction that needs to occur at a critical time period in the development of the immune system or the lung. It remains to be firmly established, however, how any one or all of these factors, either independently or interactively, influence the development of childhood asthma. Thus, our efforts to determine and define the importance of these three factors to asthma pathogenesis are the focus and goal of this current grant application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1998

Longer than P75 for all trials

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

October 1, 1998

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

20.8 years

First QC Date

September 12, 2005

Last Update Submit

July 11, 2019

Conditions

AsthmaAllergy

Outcome Measures

Primary Outcomes (1)

  • Evaluate the children longitudinally for the inception and progression of asthma.

    Clinical diagnosis of childhood asthma at age 6 years and older.

    Birth through age 19

Eligibility Criteria

Age1 Minute - 2 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

High risk birth cohort of children (one or both parents have allergies and/or asthma).

You may qualify if:

  • children who had one or more parent with a history of allergy or asthma

You may not qualify if:

  • pre term infants
  • low birth weight infants
  • respiratory distress at birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

nasal mucus samples, cord blood, peripheral blood samples, nasal cell brushing samples, cell lines

MeSH Terms

Conditions

AsthmaHypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel J Jackson, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Robert F Lemanske, Jr., MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 1998

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

US(1)