Respiratory DiseaseMRHNCT05501587
Measures of Respiratory Health Registry
An observational study of Respiratory Disease and Cystic Fibrosis, run by University of British Columbia at 1 site in Canada.
Trial summary
There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Respiratory Disease, Cystic Fibrosis
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2018to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with CF Participants with other Respiratory Disease Healthy Participants
Who may be able to join
- -Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).
- A documented genotype with two disease-causing mutations in the CFTR gene.
- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
- Physician-diagnosed lung disease
- Informed consent by participant, parent, or legal guardian
- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
- Informed consent by participant, parent, or legal guardian
- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
Who cannot join
- Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
- Requirement of supplementary oxygen to maintain oxygen saturation above 95%
- Participants with other Respiratory Disease
- Physical findings at screening that would compromise the safety of the participant or the quality of the research data
- Requirement of supplementary oxygen to maintain oxygen saturation above 95%
- Healthy Participants
- Physical findings at screening that would compromise the safety of the participant or the quality of the research data
- Evidence of lung disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Rodrigo Sandoval, MSc, 6048752345 ext. 2928, Rodrigo.Sandoval@bcchr.ca
Alam Lakhani, 6048752345 ext. 7606, alam.lakhani@cw.bc.ca
About this study
There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.
Read the detailed description
The scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (CF) and children with non-CF respiratory disease using the multiple breath washout (MBW) system. These data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (PFT) data. The MBW data will be collected with concurrent with clinically indicated PFT testing.
The purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in CF and non-CF respiratory disease.
Ultimately, the objective of this registry is to validate MBW technology as a tool that can be utilized in clinical care.
- Conditions
- Respiratory Disease, Cystic Fibrosis
- Medical subject headings
- Respiration Disorders, Cystic Fibrosis
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 |
|---|---|---|
| Participants with CF | Not described | |
| Participants with other Respiratory Disease | Not described | |
| Healthy Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate new lung function testing technologies
The ultimate objective of this registry is to validate new lung function testing technologies as tools that can be utilized in clinical care.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start11 Oct 2018
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Rayment, University of British Columbia
- Investigators
- Jonathan Rayment, MDCM, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501587
- Sponsor's protocol ID
- H18-00812
- Acronym
- MRH
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MRH-Registry Data may be shared with investigators from BCCHR/UBC or elsewhere. MRH-Registry Co-Investigators using MRH Registry Data to address the Scientific Objectives of the MRH Registry do not need to formally apply for access. All other User-Investigators (domestic and international) must apply to the MRH-Registry Data Access Committee for access to the MRH-Registry Data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measures of Respiratory Health Registry
- ClinicalTrials.gov ID
- NCT05501587
- Acronym / sponsor ID
- MRH / H18-00812
- Conditions
- Respiratory Disease, Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Aug 2022 (actual)
- 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.
There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.
Detailed description
The scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (CF) and children with non-CF respiratory disease using the multiple breath washout (MBW) system. These data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (PFT) data. The MBW data will be collected with concurrent with clinically indicated PFT testing.
The purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in CF and non-CF respiratory disease.
Ultimately, the objective of this registry is to validate MBW technology as a tool that can be utilized in clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with CF | – | – |
| Participants with other Respiratory Disease | – | – |
| Healthy Participants | – | – |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with CF Participants with other Respiratory Disease Healthy Participants
Key inclusion criteria (8 listed)
- -Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).
- A documented genotype with two disease-causing mutations in the CFTR gene.
- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
- Physician-diagnosed lung disease
- Informed consent by participant, parent, or legal guardian
Key exclusion criteria (8 listed)
- Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
- Requirement of supplementary oxygen to maintain oxygen saturation above 95%
- Participants with other Respiratory Disease
- Physical findings at screening that would compromise the safety of the participant or the quality of the research data
- Requirement of supplementary oxygen to maintain oxygen saturation above 95%
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
To validate new lung function testing technologies
Time frame: 10 years
The ultimate objective of this registry is to validate new lung function testing technologies as tools that can be utilized in clinical care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: Yes. MRH-Registry Data may be shared with investigators from BCCHR/UBC or elsewhere. MRH-Registry Co-Investigators using MRH Registry Data to address the Scientific Objectives of the MRH Registry do not need to formally apply for access. All other User-Investigators (domestic and international) must apply to the MRH-Registry Data Access Committee for access to the MRH-Registry Data.
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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.
Jonathan Rayment, MDCM, MSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Cystic Fibrosis, run by University of British Columbia at 1 site in Canada.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Sandoval, MSc (6048752345 ext. 2928, Rodrigo.Sandoval@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate new lung function testing technologies (time frame: 10 years). 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 15 Aug 2022.