Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-Term Examination of Asthma From Childhood Through Adolescence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541255
Recruitment Status : Unknown
Verified October 2015 by Professor S Hasan Arshad, Isle of Wight NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2007
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Professor S Hasan Arshad, Isle of Wight NHS Trust

Tracking Information
First Submitted Date October 9, 2007
First Posted Date October 10, 2007
Last Update Posted Date October 7, 2015
Study Start Date September 2007
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2007)
Identifying factors that may increase a person's chance of having recurrent asthma as an adult [ Time Frame: Measured throughout the participant's lifetime ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-Term Examination of Asthma From Childhood Through Adolescence
Official Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, saliva, urine
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.
Condition
  • Asthma
  • Dermatitis, Atopic
  • Rhinitis
  • Urticaria
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 9, 2007)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Born on the Isle of Wight in the United Kingdom between January 1, 1989 and February 28, 1990

Exclusion criteria:

  • Refused consent
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00541255
Other Study ID Numbers 1408
R01HL082925 ( U.S. NIH Grant/Contract )
1R01HL082925-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor S Hasan Arshad, Isle of Wight NHS Trust
Study Sponsor Isle of Wight NHS Trust
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Syed Arshad, MD University of Southampton, United Kingdom
PRS Account Isle of Wight NHS Trust
Verification Date October 2015