Measures of Respiratory Health

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 30
Healthy Volunteers: t
View:

• 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

• 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

• 2.5 - 30 years of age at enrollment

• Informed consent by participant, parent, or legal guardian

• Ability to perform technically acceptable MBW measurements

Locations
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Felix Ratjen, MD PhD
felix.ratjen@sickkids.ca
416-813-7654
Backup
Sanja Stanojevic, PhD
sanja.stanojevic@sickkids.ca
416-813-7654
Time Frame
Start Date: 2016-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 300
Treatments
Cystic Fibrosis
Children 2.5 to 18 years old with confirmed diagnosis of cystic fibrosis
Children with other respiratory disease
Children 2.5 to 18 years old with confirmed diagnosis of respiratory disease including but not limited to asthma, transplant, and sickle cell anemia.
Healthy Children
Children and adults 2.5 to 30 years old with no history of chronic disease
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov

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