AsthmaCREW02NCT03213184
Children's Respiratory and Environmental Workgroup
An observational study of Asthma and Allergic Asthma, run by University of Wisconsin, Madison at 10 sites in United States.
Trial summary
The environment during the prenatal period and in early life is a major contributor to the risk of developing childhood asthma. Birth cohort studies from single research centers have identified several factors that affect the risk for developing childhood asthma, including being exposed in early life to allergens… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Asthma, Allergies
- How many people
- 142 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Dec 2017to 30 Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: CREW consortium represent a diverse national sample of children and families recruited over the past 30 years into 12 early life and birth cohort studies that focused on asthma. The total combined study population is 8,985 at the time of birth. The study population is quite diverse in terms of current age (ages <1 through 36 years), date of recruitment (1980-2017), race/ethnicity, and risk of asthma. There is considerable variation in the geographic locations of participants, with representation from East Coast (Baltimore, Boston, New York City), Midwest (Cincinnati, Detroit, Madison, Marshfield), South (Nashville, St. Louis) and West (Tucson). Most children are healthy (control population) while some have asthma or some form of allergic disease.
Who may be able to join
- Participant and/or parent guardian must be able to understand and provide informed consent or assent (if required).
- Participation in one of the 10 cohorts that make up CREW.
Who cannot join
- Inability or unwillingness of a participant to give informed consent or assent (if required) or comply with study protocol.
- Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Henry Ford Health System
Detroit, Michigan, 48202
UW Madison
Madison, Wisconsin, 53792
Marshfield Clinic
Marshfield, Wisconsin, 54449
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
Washington University
St Louis, Missouri, 63110
About this study
Official title: Children's Respiratory and Environmental Workgroup (CREW)02
The environment during the prenatal period and in early life is a major contributor to the risk of developing childhood asthma. Birth cohort studies from single research centers have identified several factors that affect the risk for developing childhood asthma, including being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial stress. Despite such advances, further progress in understanding the root causes of asthma have been hampered by the small size of previous studies, which makes it difficult to: 1) identify asthma risk factors with certainty, 2) know how environmental factors across the United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant mothers, infants and young children are particularly susceptible to these influences. Furthermore, different research groups tend to use different methods to study asthma, making it difficult to either compare or pool findings. One other challenge is that there are several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts across the U.S. have established the Children's Respiratory Research Workgroup (CREW) consortium. CREW proposes to identify specific types of childhood asthma, develop an understanding of what early life environmental influences cause these different types of asthma and when, and identify targets for future efforts aimed at preventing childhood asthma.
Read the detailed description
CREW is an NIH-funded project consisting of 12 individual U.S. birth cohorts and two scientific centers working together to identify phenotypes and causes of childhood asthma. CREW will include data from a large number of children (over 9,000 at birth, 6,000-7,000 who are still being followed, and at least 5,667 expected to enroll in CREW) and their families, with broad diversity in terms of ethnicity, family characteristics, neighborhoods and geographic locations. One of the primary goals of CREW is to put together sets of data and samples of participating cohorts to identify phenotypes of childhood asthma (i.e. specific subtypes of asthma that can be distinguished by clinical features such as natural history, triggers, exacerbation frequency, concurrent allergies, lung function, sex, etc). As we obtain mechanistic insights about personal and early life risk factors, we will connect asthma phenotypes with underlying causes and pathogenic mechanisms to define endotypes of childhood asthma.
- Conditions
- Asthma, Allergic Asthma, Allergies, Healthy
- Keywords
- Birth cohort, asthma, allergies
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in the first second (FEV1)
Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.
Measured: 7 years
Secondary outcomes (2)
Asthma Control Test (ACT)
Asthma symptoms of children leading to differing asthma severity (none, mild, moderate, severe) will be measured using the ACT questionnaire at all ages.
Measured: 7 years
Immunoglobulin E (IgE)
Total IgE will be measured serologically and will be used to determine level of allergy in all ages over 7 years.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start26 Dec 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Chicago, University of California, San Francisco, Harvard School of Public Health (HSPH), University of Arizona
- Responsible party
- Sponsor
- Investigators
- James Gern, MD, Principal investigator, UW MadisonDaniel Jackson, MD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213184
- Sponsor's protocol ID
- 2017-0837
- Other IDs
- 1UG3OD023282, A536700, SMPH\PEDIATRICS\PEDIATRICS, Protocol V4.0, dated 11/13/18, 5UH3OD023282-05
- Acronym
- CREW02
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Respiratory and Environmental Workgroup (CREW)02
- ClinicalTrials.gov ID
- NCT03213184
- Acronym / sponsor ID
- CREW02 / 2017-0837
- Conditions
- Asthma, Allergic Asthma, Allergies, Healthy
- Keywords
- Birth cohort, asthma, allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Chicago, University of California, San Francisco, Harvard School of Public Health (HSPH), University of Arizona
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
The environment during the prenatal period and in early life is a major contributor to the risk of developing childhood asthma. Birth cohort studies from single research centers have identified several factors that affect the risk for developing childhood asthma, including being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial stress. Despite such advances, further progress in understanding the root causes of asthma have been hampered by the small size of previous studies, which makes it difficult to: 1) identify asthma risk factors with certainty, 2) know how environmental factors across the United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant mothers, infants and young children are particularly susceptible to these influences. Furthermore, different research groups tend to use different methods to study asthma, making it difficult to either compare or pool findings. One other challenge is that there are several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts across the U.S. have established the Children's Respiratory Research Workgroup (CREW) consortium. CREW proposes to identify specific types of childhood asthma, develop an understanding of what early life environmental influences cause these different types of asthma and when, and identify targets for future efforts aimed at preventing childhood asthma.
Detailed description
CREW is an NIH-funded project consisting of 12 individual U.S. birth cohorts and two scientific centers working together to identify phenotypes and causes of childhood asthma. CREW will include data from a large number of children (over 9,000 at birth, 6,000-7,000 who are still being followed, and at least 5,667 expected to enroll in CREW) and their families, with broad diversity in terms of ethnicity, family characteristics, neighborhoods and geographic locations. One of the primary goals of CREW is to put together sets of data and samples of participating cohorts to identify phenotypes of childhood asthma (i.e. specific subtypes of asthma that can be distinguished by clinical features such as natural history, triggers, exacerbation frequency, concurrent allergies, lung function, sex, etc). As we obtain mechanistic insights about personal and early life risk factors, we will connect asthma phenotypes with underlying causes and pathogenic mechanisms to define endotypes of childhood asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CREW consortium represent a diverse national sample of children and families recruited over the past 30 years into 12 early life and birth cohort studies that focused on asthma. The total combined study population is 8,985 at the time of birth. The study population is quite diverse in terms of current age (ages <1 through 36 years), date of recruitment (1980-2017), race/ethnicity, and risk of asthma. There is considerable variation in the geographic locations of participants, with representation from East Coast (Baltimore, Boston, New York City), Midwest (Cincinnati, Detroit, Madison, Marshfield), South (Nashville, St. Louis) and West (Tucson). Most children are healthy (control population) while some have asthma or some form of allergic disease.
Key inclusion criteria (2 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent or assent (if required).
- Participation in one of the 10 cohorts that make up CREW.
Key exclusion criteria (2 listed)
- Inability or unwillingness of a participant to give informed consent or assent (if required) or comply with study protocol.
- Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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
Forced Expiratory Volume in the first second (FEV1)
Time frame: 7 years
Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.
2 secondary outcomes
Asthma Control Test (ACT)
Time frame: 7 years
Immunoglobulin E (IgE)
Time frame: 7 years
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
James Gern, MD principal investigator
UW Madison
Daniel Jackson, MD principal investigator
UW Madison
10 sites 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 Allergic Asthma, run by University of Wisconsin, Madison at 10 sites 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 2 inclusion and 2 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Forced Expiratory Volume in the first second (FEV1) (time frame: 7 years). 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 14 Aug 2023.