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Measures of Respiratory Health (MRH) (MRH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02657837
First received: January 8, 2016
Last updated: October 13, 2016
Last verified: October 2016
  Purpose
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.

Condition
Cystic Fibrosis
Asthma
Sickle Cell Anemia
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measures of Respiratory Health

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Proportion of patients with an abnormal Lung Clearance Index (>7.5). [ Time Frame: Day 1 ]
    Single time point measurements obtained in enrolled subjects


Secondary Outcome Measures:
  • . Proportion of patients with an abnormal pulmonary function tests based on spirometry. [ Time Frame: Day 1 ]
    Single time point measurements obtained in enrolled subjects


Estimated Enrollment: 300
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

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
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02657837

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

Locations
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         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Felix Ratjen, MD PhD The Hospital for Sick Children
  More Information

Publications:

Responsible Party: Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02657837     History of Changes
Other Study ID Numbers: 1000051399
Study First Received: January 8, 2016
Last Updated: October 13, 2016

Keywords provided by The Hospital for Sick Children:
CF
Multiple Breath Washout
Lung Clearance Index
Pediatrics

Additional relevant MeSH terms:
Cystic Fibrosis
Bronchiolitis
Anemia, Sickle Cell
Bronchiolitis Obliterans
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies

ClinicalTrials.gov processed this record on March 28, 2017