Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05501587

Conditions

Respiratory Disease

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Respiratory Disease

Cystic Fibrosis

Study ID

NCT05501587

Start date

Oct 11, 2018

Status verified date

Aug, 2022

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with CF

Participants with other Respiratory Disease

Healthy Participants

Primary outcome measure

  • To validate new lung function testing technologies [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Principal Investigator:

Jonathan Rayment, MDCM, MSc

More Information

Sponsor

University of British Columbia

Last update posted

Aug 15, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-08-15.