HealthyHV-LCINCT03447418
Multiple Breath Nitrogen Washout in Healthy Volunteers
A study testing Multiple breath nitrogen washout in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood) Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Multiple breath nitrogen washout
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2018to Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Informed consent by participant, parent, or legal guardian
- Healthy subjects with a social insurance
Who cannot join
- History of a lung chronic disease
- Premature birth (<37th weeks of amenorrhea)
- Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Bron
Philippe REIX, Pr
About this study
This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)
- Conditions
- Healthy
- Being tested
- Multiple breath nitrogen washout
- Keywords
- Lung Clearance Index, Breath Nitrogen Washout, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple breath nitrogen washoutProcedure or surgery
Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.
| Study group | Role | What they receive |
|---|---|---|
| no treatment, open label | Other | Not described Receives: Procedure: Multiple breath nitrogen washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index 2.5% (LCI 2.5%) Value
Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity.
LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed.
Measured: hour 1
Secondary outcomes (5)
Lung Clearance Index 5% (LCI 5%) Value
Measured: hour 1
Moment ratio M1/M0 Value
Measured: up to 1 hour
Moment ratio M0/M2 Value
Measured: up to 1 hour
Sacin value
assessment of distal areas function
Measured: hour 1
Scond value
assessment of conductive areas function
Measured: hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start6 Jul 2018
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447418
- Sponsor's protocol ID
- 69HCL18_0064
- Acronym
- HV-LCI
- Status last verified
- Jan 2021
- First submitted
- 19 Feb 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Breath Nitrogen Washout in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03447418
- Acronym / sponsor ID
- HV-LCI / 69HCL18_0064
- Conditions
- Healthy
- Keywords
- Lung Clearance Index, Breath Nitrogen Washout, Healthy subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 27 Feb 2018 (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 study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment, open label | Other | Procedure: Multiple breath nitrogen washout |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent by participant, parent, or legal guardian
- Healthy subjects with a social insurance
Key exclusion criteria (3 listed)
- History of a lung chronic disease
- Premature birth (<37th weeks of amenorrhea)
- Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout
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 |
|---|---|---|
| Multiple breath nitrogen washoutLung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device. | Procedure or surgery | no treatment, open label |
Primary outcome
Lung Clearance Index 2.5% (LCI 2.5%) Value
Time frame: hour 1
Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity. LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed.
5 secondary outcomes
Lung Clearance Index 5% (LCI 5%) Value
Time frame: hour 1
Moment ratio M1/M0 Value
Time frame: up to 1 hour
Moment ratio M0/M2 Value
Time frame: up to 1 hour
Sacin value
Time frame: hour 1
Scond value
Time frame: hour 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple breath nitrogen washout in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe REIX, Pr (427 85 54 70 ext. +33, philippe.reix@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Clearance Index 2.5% (LCI 2.5%) Value (time frame: hour 1). 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 27 Jan 2021.