AsthmaNCT00461227
Effect of Heredity and Environment on Asthma Development and Severity in Puerto Rican Children
An observational study of Asthma and Hypersensitivity, run by University of Pittsburgh at 1 site in Puerto Rico.
Trial summary
Asthma is a major public health problem among Puerto Ricans. Little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma, Hypersensitivity
- How many people
- 1,127 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Aug 2006to Jun 2010
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children of Puerto Rican descent (having four Puerto Rican grandparents) living in Hartford (Connecticut) and in the metropolitan areas of San Juan and Caguas in the island of Puerto Rico.
Who may be able to join
- For participants with asthma:
- Diagnosis of asthma
- History of wheezing within 12 months prior to study entry
- Has four grandparents that were born in Puerto Rico
- For participants without asthma:
- No diagnosis of asthma
- No history of wheezing within 12 months prior to study entry
- Has four grandparents that were born in Puerto Rico
Who cannot join
- Significant pulmonary disease other than asthma
- Hospitalization in the neonatal intensive care unit and requiring ventilatory support
- History of cigarette smoking for more than 5 pack-years ([number of packs smoked per day] x [number of years of smoking])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genes, Home Allergens, and Asthma in Puerto Rican Children
Asthma is a major public health problem among Puerto Ricans. Little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. This study will examine the relationship between asthma and certain genetic and environmental factors in Puerto Rican children.
Read the detailed description
Asthma is a chronic disease that causes constriction of the airways. People with asthma may experience wheezing, coughing, chest tightness, and trouble breathing. Although asthma is a major public health problem among Puerto Ricans, little research has been done to determine the influence of heredity and environment on the disease in this population. To learn more about these relationships, this study will examine the effects of certain genes and allergens on the development and severity of asthma in Puerto Rican children.
This observational study will recruit both children with asthma and children without asthma. Participants will meet with study staff twice during the study. The first visit will take place at participants' homes. Participants will complete questionnaires about demographics, respiratory and general health, and household characteristics. Lung function testing, collection of blood samples, and collection of household dust samples will also take place at the home-based visit. The second visit will take place at the study site. At this visit, participants will undergo allergy tests on the skin and a methacholine challenge test to assess their airway responsiveness and asthma severity. The methacholine challenge test will involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus called a spirometer. Parents will be asked to provide information about their children's exposure to pets in early life. Each visit will last approximately 1.5 hours and will be scheduled close to the date on which a participant enters the study.
- Conditions
- Asthma, Hypersensitivity
- Keywords
- Puerto Rican, Allergies
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of certain genes and allergens on the development and severity of asthma in Puerto Rican children
Measured: Measured at participants' two study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionJun 2010
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 PittsburghThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Juan Celedon, MD, University of Pittsburgh
- Investigators
- Juan C. Celedon, MD, DrPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461227
- Sponsor's protocol ID
- 1353
- Other IDs
- R01HL079966-01A2
- Status last verified
- Dec 2012
- First submitted
- 13 Apr 2007
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genes, Home Allergens, and Asthma in Puerto Rican Children
- ClinicalTrials.gov ID
- NCT00461227
- Acronym / sponsor ID
- 1353
- Conditions
- Asthma, Hypersensitivity
- Keywords
- Puerto Rican, Allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,127 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Apr 2007 (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.
Asthma is a major public health problem among Puerto Ricans. Little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. This study will examine the relationship between asthma and certain genetic and environmental factors in Puerto Rican children.
Detailed description
Asthma is a chronic disease that causes constriction of the airways. People with asthma may experience wheezing, coughing, chest tightness, and trouble breathing. Although asthma is a major public health problem among Puerto Ricans, little research has been done to determine the influence of heredity and environment on the disease in this population. To learn more about these relationships, this study will examine the effects of certain genes and allergens on the development and severity of asthma in Puerto Rican children.
This observational study will recruit both children with asthma and children without asthma. Participants will meet with study staff twice during the study. The first visit will take place at participants' homes. Participants will complete questionnaires about demographics, respiratory and general health, and household characteristics. Lung function testing, collection of blood samples, and collection of household dust samples will also take place at the home-based visit. The second visit will take place at the study site. At this visit, participants will undergo allergy tests on the skin and a methacholine challenge test to assess their airway responsiveness and asthma severity. The methacholine challenge test will involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus called a spirometer. Parents will be asked to provide information about their children's exposure to pets in early life. Each visit will last approximately 1.5 hours and will be scheduled close to the date on which a participant enters the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children of Puerto Rican descent (having four Puerto Rican grandparents) living in Hartford (Connecticut) and in the metropolitan areas of San Juan and Caguas in the island of Puerto Rico.
Key inclusion criteria (8 listed)
- Diagnosis of asthma
- History of wheezing within 12 months prior to study entry
- Has four grandparents that were born in Puerto Rico
- No diagnosis of asthma
- No history of wheezing within 12 months prior to study entry
Key exclusion criteria (3 listed)
- Significant pulmonary disease other than asthma
- Hospitalization in the neonatal intensive care unit and requiring ventilatory support
- History of cigarette smoking for more than 5 pack-years ([number of packs smoked per day] x [number of years of smoking])
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
Effect of certain genes and allergens on the development and severity of asthma in Puerto Rican children
Time frame: Measured at participants' two study visits
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 19 Dec 2012.
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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.
Juan C. Celedon, MD, DrPH principal investigator
Brigham and Women's Hospital
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 Hypersensitivity, run by University of Pittsburgh at 1 site in Puerto Rico.
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 8 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 19 Dec 2012. 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 Puerto Rico. 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?
Effect of certain genes and allergens on the development and severity of asthma in Puerto Rican children (time frame: Measured at participants' two study visits). 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 19 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.