Benign Joint Hypermobility SyndromeNCT02163096
A Study to Assess Benign Joint Hypermobility Syndrome in Children With a History of Wheezing or Asthma
An observational study of Benign Joint Hypermobility Syndrome and Wheezing, run by University of Louisville at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Benign Joint Hypermobility Syndrome, Wheezing, Asthma
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 6-16 in Primary Care Clinic and Pediatric Subspecialty Clinics of Pulmonary and Allergy/Immunology.
Who may be able to join
- All children ages 6-16 with a history of wheezing or asthma
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Louisville - Sam Swope Kosair Charities Centre
Louisville, Kentucky, 40202
University of Louisville Allergy and Immunology
Louisville, Kentucky, 40202
University of Louisville Pediatric Pulmonology
Louisville, Kentucky, 40202
About this study
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:
- 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
- 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
- Medical subject headings
- Respiratory Sounds, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| History of Wheezing, Benign Joint Hypermobility Syndrome | Not described | |
| Asthma, Benign Joint Hypermobility Syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Joint Hypermobility SyndromeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald L. Morton, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163096
- Sponsor's protocol ID
- 14.0447
- Status last verified
- Jan 2016
- First submitted
- 10 Jun 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Benign Joint Hypermobility Syndrome in Children With a History of Wheezing or Asthma
- ClinicalTrials.gov ID
- NCT02163096
- Acronym / sponsor ID
- 14.0447
- Conditions
- Benign Joint Hypermobility Syndrome, Wheezing, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of Wheezing, Benign Joint Hypermobility Syndrome | – | – |
| Asthma, Benign Joint Hypermobility Syndrome | – | – |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 6-16 in Primary Care Clinic and Pediatric Subspecialty Clinics of Pulmonary and Allergy/Immunology.
Key inclusion criteria (1 listed)
- All children ages 6-16 with a history of wheezing or asthma
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Joint Hypermobility Syndrome and Wheezing, run by University of Louisville at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine correlation between BJHS and Wheezing/Asthma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.