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

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: NCT02163096
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ronald L. Morton, University of Louisville

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. 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.

Condition or disease
Benign Joint Hypermobility Syndrome Wheezing Asthma

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
History of Wheezing, Benign Joint Hypermobility Syndrome
Asthma, Benign Joint Hypermobility Syndrome



Primary Outcome Measures :
  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.




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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children ages 6-16 in Primary Care Clinic and Pediatric Subspecialty Clinics of Pulmonary and Allergy/Immunology.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163096


Locations
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United States, Kentucky
University of Louisville - Sam Swope Kosair Charities Centre
Louisville, Kentucky, United States, 40202
University of Louisville Allergy and Immunology
Louisville, Kentucky, United States, 40202
University of Louisville Pediatric Pulmonology
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Responsible Party: Ronald L. Morton, Professor of Pediatrics, University of Louisville
ClinicalTrials.gov Identifier: NCT02163096    
Other Study ID Numbers: 14.0447
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Joint Instability
Asthma
Syndrome
Respiratory Sounds
Disease
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Joint Diseases
Musculoskeletal Diseases