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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 : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children

Tracking Information
First Submitted Date January 8, 2016
First Posted Date January 18, 2016
Last Update Posted Date April 10, 2019
Study Start Date January 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2016)
Proportion of patients with an abnormal Lung Clearance Index (>7.5). [ Time Frame: Day 1 ]
Single time point measurements obtained in enrolled subjects
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02657837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 13, 2016)
. Proportion of patients with an abnormal pulmonary function tests based on spirometry. [ Time Frame: Day 1 ]
Single time point measurements obtained in enrolled subjects
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measures of Respiratory Health (MRH)
Official Title Measures of Respiratory Health
Brief 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants who meet all of the inclusion and none of the exclusion criteria will be eligible for participation in this study. Participants will include individuals with CF, individuals with other respiratory disease and healthy individuals.
Condition
  • Cystic Fibrosis
  • Asthma
  • Sickle Cell Anemia
  • Bronchiolitis Obliterans
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 13, 2016)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Months to 30 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02657837
Other Study ID Numbers 1000051399
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Felix Ratjen, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Not Provided
Investigators
Principal Investigator: Felix Ratjen, MD PhD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date April 2019