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Completed

NCT Number: NCT02163096

A Study to Assess Benign Joint Hypermobility Syndrome in Children With a History of Wheezing or Asthma

The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in children with a history of wheezing or asthma. BJHS is a common syndrome of joint and connective tissue laxity without any other rheumatologic disease. This assessment will be performed by using either method below depending upon if the child has a history of wheezing or severe asthma:

1. Determine the correlation, if there is an increased rate of BJHS in children with a history of wheezing as well as if there is an increased history of wheezing in children with BJHS; or 2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute worsening of symptoms) in children with BJHS compared to children with asthma without BJHS, to assess if it BJHS is associated more with children with severe asthma.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville - Sam Swope Kosair Charities Centre, Louisville, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children ages 6-16 with a history of wheezing or asthma

Exclusion criteria

  • For subjects with a history of Wheezing: History of chronic lung disease or prematurity, chronic aspiration, congenital anomalies of the upper and lower airway, primary ciliary dyskinesia, cystic fibrosis, history of heart failure, immune deficiency, or any inflammatory arthritis.
  • For Subjects with a history of Asthma: current acute respiratory exacerbation, history of chronic lung disease of prematurity, chronic aspiration, congenital anomalies of the upper or lower airway, primary ciliary dyskinesia, cystic fibrosis, restrictive lung disease, history of heart failure, immune deficiency, or inflammatory arthritis.

Treatment and study plan

Primary outcomes

  1. Determine correlation between BJHS and Wheezing/Asthma

    Time frame: 6 months

    Determine the correlation, if there is an increased rate of BJHS in children with a history of wheezing as well as if there is an increased history of wheezing in children with BJHS, enrolled during well child visits and perform physical exams to screen for BJHS using a standardized assessment, Beighton Criteria, where a score is reached by testing the range of motion of the child's joints to determine if they are more loose than normal.

    Pediatric asthma patients will participate by, either the caregiver or child filling out a questionnaire to assess asthma control and history of exacerbation. Spirometry, a pulmonary lung function test, will be performed on all subjects along with a physical exam to screen for BJHS using standardized assessment, Beighton Criteria, where a score is reached by testing the range of motion of the child's joints to determine if they are more loose than normal.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2014
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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