Measures of Respiratory Health Registry

Cystic Fibrosis Clinical Trial

— MRH  

Official title:

Measures of Respiratory Health Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501587
• Other study ID #: H18-00812
• Status: Recruiting
• Start date: October 11, 2018
• Est. completion date: May 2028

Study information

• Verified date: August 2022
• Source: University of British Columbia
• Contact: Rodrigo Sandoval, MSc
• Phone: 6048752345
• Email: Rodrigo.Sandoval[@]bcchr.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

Participants with CF

Inclusion Criteria:

-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).

ii. 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

Exclusion Criteria:

• 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

Inclusion criteria:

• 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

Exclusion criteria

• 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

• Inclusion criteria

• 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

Exclusion criteria

• Physical findings at screening that would compromise the safety of the participant or the quality of the research data

• Evidence of lung disease

Related Conditions & MeSH terms

• Cystic Fibrosis
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years