Cystic FibrosisNCT04016194
Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout
An observational study of Cystic Fibrosis and Death, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Cystic Fibrosis, Death, Lung Transplantation
- What is being tested?
- Lung function testing
- How many people
- 200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 1990to Dec 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Non-Probability sample
Who may be able to join
- Patients treated at the Children's Hospital Bern
- Confirmed CF Diagnosis
- Age >= 3 years
Who cannot join
- Uncertain diagnosis of CF according to current standards
- Existing written or otherwise documented refusal to participate in research
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Bern
Bern, 3007
Lindenhof Spital, Quartier Bleu
Bern, 3012
About this study
Official title: Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?
Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.
Read the detailed description
Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.
- Conditions
- Cystic Fibrosis, Death, Lung Transplantation
- Being tested
- Lung function testing
- Keywords
- Multiple-breath washout, MBW, Lung clearance index, LCI, Prediction, Survival, Cystic Fibrosis, CF
- Medical subject headings
- Cystic Fibrosis, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function testingDiagnostic test
Also called Multiple-breath washout, MBW
Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung clearance index (LCI)
Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation
Measured: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary outcomes (7)
Functional residual capacity (FRC)
Lung function outcome derived by MBW
Measured: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Forced expired Volume in 1 second (FEV1)
Lung function outcome derived by Spirometry
Measured: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Body weight
Anthropometric characteristics
Measured: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Body length
Anthropometric characteristics
Measured: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Gender
Anthropometric characteristics
Measured: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Presence of Pseudomonas aeruginosa infection
Clinical characteristics
Measured: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Presence of Staphylococcus aureus infection
Clinical characteristics
Measured: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jan 1990
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Lindenhofspital
- Responsible party
- Sponsor
- Investigators
- Florian Singer, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016194
- Sponsor's protocol ID
- 3840
- Status last verified
- Jul 2019
- First submitted
- 7 May 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with researchers involved in the data collection and analysis.
Publications
Kurz JM, Ramsey KA, Rodriguez R, Spycher B, Fischer Biner R, Latzin P, Singer F. Association of lung clearance index with survival in individuals with cystic fibrosis. Eur Respir J. 2022 Mar 3;59(3):2100432. doi: 10.1183/13993003.00432-2021. Print 2022 Mar.
PubMed 34289977
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?
- ClinicalTrials.gov ID
- NCT04016194
- Acronym / sponsor ID
- 3840
- Conditions
- Cystic Fibrosis, Death, Lung Transplantation
- Keywords
- Multiple-breath washout, MBW, Lung clearance index, LCI, Prediction, Survival, Cystic Fibrosis, CF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Lindenhofspital
- Study start
- 1 Jan 1990 (actual)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 11 Jul 2019 (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.
Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.
Detailed description
Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-Probability sample
Key inclusion criteria (3 listed)
- Patients treated at the Children's Hospital Bern
- Confirmed CF Diagnosis
- Age >= 3 years
Key exclusion criteria (2 listed)
- Uncertain diagnosis of CF according to current standards
- Existing written or otherwise documented refusal to participate in research
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 |
|---|---|---|
| Lung function testingAlso: Multiple-breath washout, MBWMultiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF | Diagnostic test | – |
Primary outcome
Lung clearance index (LCI)
Time frame: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation
7 secondary outcomes
Functional residual capacity (FRC)
Time frame: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Forced expired Volume in 1 second (FEV1)
Time frame: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Body weight
Time frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Body length
Time frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Gender
Time frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Presence of Pseudomonas aeruginosa infection
Time frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Presence of Staphylococcus aureus infection
Time frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
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 11 Jul 2019.
- Derived from this study: PubMed 34289977Kurz JM, Ramsey KA, Rodriguez R, Spycher B, Fischer Biner R, Latzin P, Singer F. Association of lung clearance index with survival in individuals with cystic fibrosis. Eur Respir J. 2022 Mar 3;59(3):2100432. doi: 10.1183/13993003.00432-2021. Print 2022 Mar.
- Individual participant dataSharing planned: Yes. IPD will be shared with researchers involved in the data collection and analysis.
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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.
Florian Singer principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Death, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 3 inclusion and 2 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 (LCI) (time frame: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016194, which also lists 1 linked publication.
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 11 Jul 2019.