Measures of Respiratory Health (MRH) (MRH)
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ClinicalTrials.gov Identifier: NCT02657837 |
Recruitment Status :
Recruiting
First Posted : January 18, 2016
Last Update Posted : May 10, 2022
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Condition or disease |
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Cystic Fibrosis Asthma Sickle Cell Anemia Bronchiolitis Obliterans |
Functional abnormalities associated with lung disease such as cystic fibrosis (CF) occur in early childhood, but have historically gone undetected until the onset of clinical symptoms, at which point irreversible lung damage may have already occurred (1-3). Consequently, over the last ten years the focus of clinical care has shifted to early intervention and prevention of these structural changes. To facilitate early intervention there is a pressing need for surrogate markers of early obstructive lung disease that are also sensitive enough to detect treatment effects (4).
The Lung Clearance Index (LCI) is a promising marker for detecting early lung disease. The LCI is measured by multiple breath washout (MBW) and is an indicator of ventilation inhomogeneity. MBW is performed during quiet tidal breathing and requires minimal effort from patients. It is feasible in all age groups when adaptions are made for younger children.
While there are Health Canada licensed washout systems available that can determine LCI; these devices have not been adequately validated; thus their use in routine lung function testing is controversial. As part of an international effort to validate multiple breath washout testing to measure LCI, the specific device is licensed in Europe, but as of yet is not Health Canada approved. Thus, testing with this device is considered research. This study will utilize technology to assess lung function in patients undergoing routine lung function testing for clinical indications. 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.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Measures of Respiratory Health |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |

Group/Cohort |
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Cystic Fibrosis
Children 2.5 to 18 years old with confirmed diagnosis of cystic fibrosis
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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.
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Healthy Children
Children and adults 2.5 to 30 years old with no history of chronic disease
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- Proportion of patients with an abnormal Lung Clearance Index (>7.5). [ Time Frame: Day 1 ]Single time point measurements obtained in enrolled subjects
- . Proportion of patients with an abnormal pulmonary function tests based on spirometry. [ Time Frame: Day 1 ]Single time point measurements obtained in enrolled subjects

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Ages Eligible for Study: | 30 Months to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Participants with CF
Inclusion criteria:
- 2.5 - 18 years of age at enrolment
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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%
Participants with other respiratory disease
Inclusion criteria:
- 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
Exclusion criteria:
- Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
- Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
Healthy Participants
Inclusion criteria:
- 2.5 - 30 years of age at enrollment
- 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 or the quality of the study data.
- Evidence of a chronic disease process such as lung disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657837
Contact: Felix Ratjen, MD PhD | 416-813-7654 ext 228472 | felix.ratjen@sickkids.ca | |
Contact: Sanja Stanojevic, PhD | 416-813-7654 ext 328077 | sanja.stanojevic@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Felix Ratjen, MD PhD 416-813-7654 ext 228472 felix.ratjen@sickkids.ca | |
Sub-Investigator: Hartmut Grasemann, MD PhD | |
Sub-Investigator: Sanja Stanojevic, PhD |
Principal Investigator: | Felix Ratjen, MD PhD | The Hospital for Sick Children |
Responsible Party: | Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT02657837 |
Other Study ID Numbers: |
1000051399 |
First Posted: | January 18, 2016 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
CF Multiple Breath Washout Lung Clearance Index Pediatrics |
Bronchiolitis Cystic Fibrosis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Anemia, Sickle Cell Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Bronchitis |
Respiratory Tract Infections Infections Bronchial Diseases Lung Diseases, Obstructive Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Organizing Pneumonia Graft vs Host Disease Immune System Diseases |