Measures of Respiratory Health (MRH) (MRH)

October 19, 2023 updated by: Felix Ratjen, The Hospital for Sick Children

Measures of Respiratory Health

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Sub-Investigator:
          • Hartmut Grasemann, MD PhD
        • Sub-Investigator:
          • Sanja Stanojevic, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 30 years (Child, Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
. Proportion of patients with an abnormal pulmonary function tests based on spirometry.
Time Frame: Day 1
Single time point measurements obtained in enrolled subjects
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Felix Ratjen, MD PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimated)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000051399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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