Measures of Respiratory Health (MRH) (NCT02657837) | Clinical Trial Compass
UnknownNot Applicable
Measures of Respiratory Health (MRH)
Canada300 participantsStarted 2016-01
Plain-language summary
The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function that is considered a research tool in Canada as the device used to measure it is not approved by Health Canada. The study will assess lung function in patients undergoing routine lung function testing for clinical indications (Cystic Fibrosis and Other Respiratory Diseases). In addition, healthy controls of different ages will be asked to perform this lung function test to gain reference data that can be used to interpret LCI in patients with lung disease.
Who can participate
Age range30 Months – 30 Years
SexALL
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Inclusion criteria
✓. 2.5 - 18 years of age at enrolment
✓. 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:
✓. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
✓. A documented genotype with two disease-causing mutations in the CFTR gene
✓. Informed consent by participant, parent, or legal guardian
✓. Ability to perform technically acceptable MBW measurements
Exclusion criteria
✕. Physical findings at screening that would compromise the safety of the participant as judged by the patient's most responsible physician
✕. Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
✕. MD diagnosed lung disease and/or attending the Pulmonary Function Laboratory
✕. 2.5 - 18 years of age at enrollment
✕. Informed consent by participant, parent, or legal guardian
✕. Ability to perform technically acceptable MBW measurements
✕. Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
What they're measuring
1
Proportion of patients with an abnormal Lung Clearance Index (>7.5).