Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT02657837

Conditions

Cystic Fibrosis

Asthma

Sickle Cell Anemia

Bronchiolitis Obliterans

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Cystic Fibrosis

Asthma

Sickle Cell Anemia

Bronchiolitis Obliterans

Study ID

NCT02657837

Start date

Jan, 2016

Status verified date

Oct, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Proportion of patients with an abnormal Lung Clearance Index (>7.5). [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Oct 23, 2023

Last verified

Oct, 2023

Keywords

  • CF
  • Multiple Breath Washout
  • Lung Clearance Index
  • Pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2023-10-23.