ObservationalLCITRACKNCT03138772
Tracking CF Lung Disease Through the Early Years: Utility of the LCI
An observational study of Observational, run by Felix Ratjen at 1 site in Canada.
Trial summary
This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their… Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Observational
- How many people
- 146 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2017to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: There were 139 subjects recruited in the original preschool longitudinal study, and all participants from this original study will be invited to participate in this follow up study. We would like to recruit an additional 40 CF patients at the Hospital for Sick Children to increase our cohort size.
Who may be able to join
- Informed consent by patient or parent/legal guardian, verbal assent where appropriate
- Age 3 years to 16 years old
- Clinically stable with no signs of an acute exacerbation at enrollment visit
- Previously participated in a longitudinal MBW study at the Hospital for Sick Children and at the Riley Hospital for Children
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
- Informed consent by patient or parent/legal guardian, verbal assent where appropriate
- Age 3 years to 16 years old
- Clinically stable with no signs of an acute exacerbation at enrollment visit
Who cannot join
- Previous organ transplantation
- Chronic lung disease not related to CF, such as asthma
- Use of intravenous antibiotics or other course of oral antibiotics (excluding maintenance treatment antibiotics) within 14 days of enrollment visit
- Physical findings at screening that would compromise the safety of the participant or the quality of the study data
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.
Read the detailed description
This is a prospective observational cohort study. During the 3 year study period, each participant will be followed for a period of 2 years. The study will include quarterly measurements of the lung clearance index (LCI), as well as spirometry, for CF patients at their routine clinic visits. Parents of patients with CF will be asked to call the study nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to the clinic for assessment of lung function. CF patients will then be assessed by a CF physician to assess whether they require antibiotic treatment based on a clinicians decisions to treat with antibiotics. The treatment decision will be left to the discretion of the patient's responsible physician, who will be blinded to the MBW results. All patients who meet the symptom based definition of a pulmonary exacerbation, regardless of treatment decision, will have MBW measured after 4 weeks. Following these visits at the time of an exacerbation, patients will have their MBW measured at their next clinic visit (usually within 3 months), and every 3 months thereafter until the end of the 2 year observation period, or the repeat onset of symptoms.This study will capture a maximum of two exacerbations per patient over the 2 year study period.
- Conditions
- Observational
- Being tested
- This is an observational study, no intervention used.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study, no intervention used.Other
No intervention is being used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | No intervention. Only monitoring LCI Receives: Other: This is an observational study, no intervention used. | |
| Cystic Fibrosis Patients | No intervention. Only monitoring LCI Receives: Other: This is an observational study, no intervention used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index
Outcome measure from the Multiple Breath Washout test.
Measured: an average of 2 years
Secondary outcomes (4)
Spirometry
FEV1
Measured: an average of 2 years
Respiratory Cultures
Bacterial pathogens IL-8 and neutrophil elastase
Measured: an average of 2 years
Respiratory Symptoms
CFQ-R
Measured: an average of 2 years
Respiratory Symptoms
CFRSD-CRISS
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start5 Oct 2017
- Primary completion1 Oct 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felix Ratjen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felix Ratjen, The Hospital for Sick Children
- Investigators
- Felix Ratjen, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138772
- Sponsor's protocol ID
- 1000055762
- Acronym
- LCITRACK
- Status last verified
- Sep 2021
- First submitted
- 27 Apr 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking CF Lung Disease Through the Early Years: Utility of the LCI
- ClinicalTrials.gov ID
- NCT03138772
- Acronym / sponsor ID
- LCITRACK / 1000055762
- Conditions
- Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Felix RatjenUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.
Detailed description
This is a prospective observational cohort study. During the 3 year study period, each participant will be followed for a period of 2 years. The study will include quarterly measurements of the lung clearance index (LCI), as well as spirometry, for CF patients at their routine clinic visits. Parents of patients with CF will be asked to call the study nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to the clinic for assessment of lung function. CF patients will then be assessed by a CF physician to assess whether they require antibiotic treatment based on a clinicians decisions to treat with antibiotics. The treatment decision will be left to the discretion of the patient's responsible physician, who will be blinded to the MBW results. All patients who meet the symptom based definition of a pulmonary exacerbation, regardless of treatment decision, will have MBW measured after 4 weeks. Following these visits at the time of an exacerbation, patients will have their MBW measured at their next clinic visit (usually within 3 months), and every 3 months thereafter until the end of the 2 year observation period, or the repeat onset of symptoms.This study will capture a maximum of two exacerbations per patient over the 2 year study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: This is an observational study, no intervention used.No intervention. Only monitoring LCI |
| Cystic Fibrosis Patients | – | Other: This is an observational study, no intervention used.No intervention. Only monitoring LCI |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- There were 139 subjects recruited in the original preschool longitudinal study, and all participants from this original study will be invited to participate in this follow up study. We would like to recruit an additional 40 CF patients at the Hospital for Sick Children to increase our cohort size.
Key inclusion criteria (8 listed)
- Informed consent by patient or parent/legal guardian, verbal assent where appropriate
- Age 3 years to 16 years old
- Clinically stable with no signs of an acute exacerbation at enrollment visit
- Previously participated in a longitudinal MBW study at the Hospital for Sick Children and at the Riley Hospital for Children
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Key exclusion criteria (4 listed)
- Previous organ transplantation
- Chronic lung disease not related to CF, such as asthma
- Use of intravenous antibiotics or other course of oral antibiotics (excluding maintenance treatment antibiotics) within 14 days of enrollment visit
- Physical findings at screening that would compromise the safety of the participant or the quality of the study data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study, no intervention used.No intervention is being used in this study. | Other | Cystic Fibrosis Patients, Healthy Controls |
Primary outcome
Lung Clearance Index
Time frame: an average of 2 years
Outcome measure from the Multiple Breath Washout test.
4 secondary outcomes
Spirometry
Time frame: an average of 2 years
Respiratory Cultures
Time frame: an average of 2 years
Respiratory Symptoms
Time frame: an average of 2 years
Respiratory Symptoms
Time frame: an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Ratjen, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational, run by Felix Ratjen at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Clearance Index (time frame: an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.