A Long-Term Examination of Asthma From Childhood Through Adolescence
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 9, 2007 | ||||
| Last Updated Date | March 5, 2009 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Identifying factors that may increase a person's chance of having recurrent asthma as an adult [ Time Frame: Measured throughout the participant's lifetime ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00541255 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Long-Term Examination of Asthma From Childhood Through Adolescence | ||||
| Official Title ICMJE | Epidemiology of Asthma and Allergic Disease: Risk and Prognosis in a Cohort From Birth to Adolescence | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, serum, saliva, urine |
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| Sampling Method | Non-Probability Sample | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Estimated Completion Date | May 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 17 Years to 19 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00541255 | ||||
| Other Study ID Numbers ICMJE | 1408, 1 R01 HL082925-01A2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. S. Hasan Arshad/Conusltant, Isle of Wight NHS Primary Care Trust | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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