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

NCT02163096 | Completed

• 1 other identifier: 14.0447
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 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.

Conditions

Benign Joint Hypermobility Syndrome; Wheezing; Asthma

Outcome Measures

Primary Outcomes (1)

• Determine correlation between BJHS and Wheezing/Asthma

  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.

  6 months

Study Arms (2)

History of Wheezing, Benign Joint Hypermobility Syndrome

Asthma, Benign Joint Hypermobility Syndrome

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 6-16 in Primary Care Clinic and Pediatric Subspecialty Clinics of Pulmonary and Allergy/Immunology.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (3)

University of Louisville - Sam Swope Kosair Charities Centre

Louisville, Kentucky, 40202, United States

Location

University of Louisville Allergy and Immunology

Louisville, Kentucky, 40202, United States

Location

University of Louisville Pediatric Pulmonology

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Respiratory Sounds; Asthma

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (3)