AsthmaNCT00541255
A Long-Term Examination of Asthma From Childhood Through Adolescence
An observational study of Asthma and Dermatitis, Atopic, run by Isle of Wight NHS Trust at 1 site in United Kingdom.
Trial summary
Asthma is a common disease that is often diagnosed in childhood. In some teenagers, asthma symptoms disappear and treatment can be stopped; however, for some of these people, asthma symptoms return in adulthood. Read more about this study
- Who is it for?
- Ages 17 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Dermatitis, Atopic, Rhinitis
- How many people
- 1,313 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to 18 Feb 2015
- 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 17 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of around 1500 unselected subjects (now age 18) who were recruited at birth. This is a homogenous population with 99% being Caucasians.
Who may be able to join
- Born on the Isle of Wight in the United Kingdom between January 1, 1989 and February 28, 1990
Who cannot join
- Refused consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The David Hide Asthma and Allergy Research Centre
Newport, Isle Of Wight, PO305TG
About this study
Official title: Epidemiology of Asthma and Allergic Disease: Risk and Prognosis in a Cohort From Birth to Adolescence
Asthma is a common disease that is often diagnosed in childhood. In some teenagers, asthma symptoms disappear and treatment can be stopped; however, for some of these people, asthma symptoms return in adulthood. This study will examine data collected over the lifetime of 18-year olds to identify factors that may increase a person's chance of having recurrent asthma as an adult.
Read the detailed description
Asthma is a serious, long-term illness that affects around 15% of children in the United States. During adolescence, up to 50% of teenagers stop experiencing symptoms and are able to discontinue treatment. However, asthma symptoms often reoccur in adulthood for many of these people. It is not known exactly what causes this recurrence, but potential risk factors may include obesity, elevated serum leptin levels, early onset of puberty, exposure to pollutants, parental smoking habits, and lack of breastfeeding. Additionally, it is not known why childhood asthma is initially more prevalent in boys, but during adolescence it becomes more prevalent in girls. Beginning in 1989, a group of children born on the Isle of Wight in the United Kingdom has been followed by study researchers to provide long-term information on asthma. These children have been periodically evaluated over the years and are now 18 years old. The purpose of this study is to analyze participants' data collected over a span of 18 years to identify factors that may increase a person's risk of experiencing persistent or recurrent asthma in adulthood.
At previous study visits that occurred when participants were 1, 2, 4, and 10 years old, information on the following was collected: asthma and other allergic diseases, family history of asthma, and early life risk factors, including breastfeeding and tobacco smoke exposure. A blood sample was collected at participants' 10-year study visit. For this current study, all 18-year-old participants will return for a study visit. Participants will complete questionnaires on asthma and allergy symptoms and environmental exposures, including tobacco smoke and pollution. Blood collection, an allergy skin prick test, lung function testing, and a bronchial challenge test to assess airway function will occur. Select participants will also have a sputum sample collected.
- Conditions
- Asthma, Dermatitis, Atopic, Rhinitis, Urticaria
- Keywords
- Bronchial Asthma, Food Allergy, Bronchial Hyperresponsiveness
- Medical subject headings
- Asthma, Dermatitis, Atopic, Rhinitis, Urticaria, Food Hypersensitivity, Bronchial Hyperreactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying factors that may increase a person's chance of having recurrent asthma as an adult
Measured: Measured throughout the participant's lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2012
- Study completion18 Feb 2015
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.
- 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
- 1,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isle of Wight NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Professor S Hasan Arshad, Isle of Wight NHS Trust
- Investigators
- Syed Arshad, MD, Principal investigator, University of Southampton, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541255
- Sponsor's protocol ID
- 1408
- Other IDs
- R01HL082925, 1R01HL082925-01A2
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2007
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Asthma and Allergic Disease: Risk and Prognosis in a Cohort From Birth to Adolescence
- ClinicalTrials.gov ID
- NCT00541255
- Acronym / sponsor ID
- 1408
- Conditions
- Asthma, Dermatitis, Atopic, Rhinitis, Urticaria
- Keywords
- Bronchial Asthma, Food Allergy, Bronchial Hyperresponsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,313 participants (actual)
- Lead sponsor
- Isle of Wight NHS TrustUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2007
- Primary completion
- May 2012 (actual)
- Study completion
- 18 Feb 2015 (actual)
- First posted
- 10 Oct 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 common disease that is often diagnosed in childhood. In some teenagers, asthma symptoms disappear and treatment can be stopped; however, for some of these people, asthma symptoms return in adulthood. This study will examine data collected over the lifetime of 18-year olds to identify factors that may increase a person's chance of having recurrent asthma as an adult.
Detailed description
Asthma is a serious, long-term illness that affects around 15% of children in the United States. During adolescence, up to 50% of teenagers stop experiencing symptoms and are able to discontinue treatment. However, asthma symptoms often reoccur in adulthood for many of these people. It is not known exactly what causes this recurrence, but potential risk factors may include obesity, elevated serum leptin levels, early onset of puberty, exposure to pollutants, parental smoking habits, and lack of breastfeeding. Additionally, it is not known why childhood asthma is initially more prevalent in boys, but during adolescence it becomes more prevalent in girls. Beginning in 1989, a group of children born on the Isle of Wight in the United Kingdom has been followed by study researchers to provide long-term information on asthma. These children have been periodically evaluated over the years and are now 18 years old. The purpose of this study is to analyze participants' data collected over a span of 18 years to identify factors that may increase a person's risk of experiencing persistent or recurrent asthma in adulthood.
At previous study visits that occurred when participants were 1, 2, 4, and 10 years old, information on the following was collected: asthma and other allergic diseases, family history of asthma, and early life risk factors, including breastfeeding and tobacco smoke exposure. A blood sample was collected at participants' 10-year study visit. For this current study, all 18-year-old participants will return for a study visit. Participants will complete questionnaires on asthma and allergy symptoms and environmental exposures, including tobacco smoke and pollution. Blood collection, an allergy skin prick test, lung function testing, and a bronchial challenge test to assess airway function will occur. Select participants will also have a sputum sample collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of around 1500 unselected subjects (now age 18) who were recruited at birth. This is a homogenous population with 99% being Caucasians.
Key inclusion criteria (1 listed)
- Born on the Isle of Wight in the United Kingdom between January 1, 1989 and February 28, 1990
Key exclusion criteria (1 listed)
- Refused consent
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
Identifying factors that may increase a person's chance of having recurrent asthma as an adult
Time frame: Measured throughout the participant's lifetime
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 1 Mar 2023.
- Click here for The David Hide Asthma and Allergy Research Centre Web siteLink 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.
Syed Arshad, MD principal investigator
University of Southampton, United Kingdom
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 Dermatitis, Atopic, run by Isle of Wight NHS Trust at 1 site in United Kingdom.
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 1 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 1 Mar 2023. 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 Kingdom. 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?
Identifying factors that may increase a person's chance of having recurrent asthma as an adult (time frame: Measured throughout the participant's lifetime). 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 1 Mar 2023.