AsthmaCOASTNCT00204841
Childhood Origins of Asthma (COAST)
An observational study of Asthma and Allergy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 minute to 2 minutes
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1998to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 minutes
- All sexes
- No healthy volunteers
- Child
Study population: High risk birth cohort of children (one or both parents have allergies and/or asthma).
Who may be able to join
- children who had one or more parent with a history of allergy or asthma
Who cannot join
- pre term infants
- low birth weight infants
- respiratory distress at birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhinovirus Infection and Asthma in Childhood and Adolescents
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.
Read the detailed description
No more description necessary.
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the children longitudinally for the inception and progression of asthma.
Clinical diagnosis of childhood asthma at age 6 years and older.
Measured: Birth through age 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 1998
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Daniel J Jackson, MD, Principal investigator, University of Wisconsin, MadisonRobert F Lemanske, Jr., MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204841
- Sponsor's protocol ID
- 1998-129
- Other IDs
- P01HL070831, 2013-0144, H-2007-0044
- Acronym
- COAST
- Status last verified
- Jul 2019
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhinovirus Infection and Asthma in Childhood and Adolescents
- ClinicalTrials.gov ID
- NCT00204841
- Acronym / sponsor ID
- COAST / 1998-129
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 1998 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
No more description necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 2 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- High risk birth cohort of children (one or both parents have allergies and/or asthma).
Key inclusion criteria (1 listed)
- children who had one or more parent with a history of allergy or asthma
Key exclusion criteria (3 listed)
- pre term infants
- low birth weight infants
- respiratory distress at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the children longitudinally for the inception and progression of asthma.
Time frame: Birth through age 19
Clinical diagnosis of childhood asthma at age 6 years and older.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- study web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Jackson, MD principal investigator
University of Wisconsin, Madison
Robert F Lemanske, Jr., MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the children longitudinally for the inception and progression of asthma. (time frame: Birth through age 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.