Measures of Respiratory Health (MRH)

Launched by THE HOSPITAL FOR SICK CHILDREN · Jan 13, 2016

Keywords

ClinConnect Summary

This clinical trial, called Measures of Respiratory Health (MRH), is studying how well the lungs work in patients with conditions like cystic fibrosis, asthma, sickle cell anemia, and bronchiolitis obliterans. Researchers want to use a special test called the Lung Clearance Index (LCI) to measure lung function. This test is still being researched in Canada and isn't yet approved for regular use. The trial will also include healthy volunteers of different ages to help create a comparison for understanding LCI results in patients with lung diseases.

To be eligible for the study, participants with cystic fibrosis need to be between 2.5 and 18 years old and have a confirmed diagnosis. Those with other lung diseases must also be aged 2.5 to 18, while healthy participants can be aged 2.5 to 30. All participants will need to provide consent and should be able to complete the lung function test. Throughout the trial, participants can expect to undergo routine lung function testing, and their safety will always be the top priority. This research aims to improve our understanding of lung health in children and young adults, potentially leading to better treatments in the future.

Gender

ALL

Eligibility criteria

• • Participants with CF
• Inclusion criteria:
• • 1. 2.5 - 18 years of age at enrolment
• 2. 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:
• • 1. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
• • 2. A documented genotype with two disease-causing mutations in the CFTR gene
• • 3. Informed consent by participant, parent, or legal guardian
• • 4. Ability to perform technically acceptable MBW measurements
• Exclusion criteria:
• • 1. Physical findings at screening that would compromise the safety of the participant as judged by the patient's most responsible physician
• • 2. Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
• • Participants with other respiratory disease
• Inclusion criteria:
• • 1. MD diagnosed lung disease and/or attending the Pulmonary Function Laboratory
• • 2. 2.5 - 18 years of age at enrollment
• • 3. Informed consent by participant, parent, or legal guardian
• • 4. Ability to perform technically acceptable MBW measurements
• Exclusion criteria:
• • 1. Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
• • 2. Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
• • Healthy Participants
• Inclusion criteria:
• • 1. 2.5 - 30 years of age at enrollment
• • 2. Informed consent by participant, parent, or legal guardian
• • 3. Ability to perform technically acceptable MBW measurements
• Exclusion criteria:
• • 1. Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
• • 2. Evidence of a chronic disease process such as lung disease