Measures of Respiratory Health (MRH) (MRH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657837|
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : May 10, 2022
|Condition or disease|
|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|
|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|
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.
Children and adults 2.5 to 30 years old with no history of chronic disease
- 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
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 email@example.com|
|Contact: Sanja Stanojevic, PhD||416-813-7654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Felix Ratjen, MD PhD 416-813-7654 ext 228472 email@example.com|
|Sub-Investigator: Hartmut Grasemann, MD PhD|
|Sub-Investigator: Sanja Stanojevic, PhD|
|Principal Investigator:||Felix Ratjen, MD PhD||The Hospital for Sick Children|