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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT02657837 |
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Date of registration:
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08/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Measures of Respiratory Health (MRH)
MRH |
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Scientific title:
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Measures of Respiratory Health |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02657837 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Felix Ratjen, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Name:
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Felix Ratjen, MD PhD |
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Address:
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Telephone:
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416-813-7654 |
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Email:
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felix.ratjen@sickkids.ca |
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Affiliation:
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Name:
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Felix Ratjen, MD PhD |
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Address:
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Telephone:
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416-813-7654 |
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Email:
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felix.ratjen@sickkids.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Months
Age maximum:
30 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sickle Cell Anemia
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Asthma
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Cystic Fibrosis
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Bronchiolitis Obliterans
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Primary Outcome(s)
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Proportion of patients with an abnormal Lung Clearance Index (>7.5).
[Time Frame: Day 1]
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Secondary Outcome(s)
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. Proportion of patients with an abnormal pulmonary function tests based on spirometry.
[Time Frame: Day 1]
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Secondary ID(s)
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1000051399
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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