Lung Disease ChronicNCT06455800
Severe Lung Disease in Childhood
An observational study of Lung Disease Chronic, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Lung Disease Chronic
- What is being tested?
- lung function measurements
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2024to 31 Dec 2039
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with severe chronic lung desease
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hans Christian Andersen Children's Hospital
Odense, 5000
Josefine Gradman, PhD, 0045 29241375, josefine.gradman@rsyd.dk
About this study
Official title: Long Term Outcome of Severe Lung Disease in Childhood
Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few.
This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.
Read the detailed description
All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database.
At a yearly follow up, data from the patient record will be registered. Informed consent from the patients and/or their parents will be obtained. Registered data will include height, weight, results of lung function tests and imaging diagnostics.
The study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.
- Conditions
- Lung Disease Chronic
- Being tested
- lung function measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung function measurementsDiagnostic test
Patients will once a year be monitored with different lung function methods
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
liter
Measured: 18 years
FVC
liter
Measured: 18 years
Lung Clearance Index (LCI)
number
Measured: 18 years
Secondary outcomes (1)
height
meters
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2039 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Disease ChronicStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josefine Gradman, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455800
- Sponsor's protocol ID
- HCA-Lung
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Severe Lung Disease in Childhood
- ClinicalTrials.gov ID
- NCT06455800
- Acronym / sponsor ID
- HCA-Lung
- Conditions
- Lung Disease Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 12 Jun 2024 (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.
Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few.
This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.
Detailed description
All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database.
At a yearly follow up, data from the patient record will be registered. Informed consent from the patients and/or their parents will be obtained. Registered data will include height, weight, results of lung function tests and imaging diagnostics.
The study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with severe chronic lung desease
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 measurementsPatients will once a year be monitored with different lung function methods | Diagnostic test | – |
Primary outcome
FEV1
Time frame: 18 years
liter
FVC
Time frame: 18 years
liter
Lung Clearance Index (LCI)
Time frame: 18 years
number
1 secondary outcome
height
Time frame: 18 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
Josefine Gradman, PhD principal investigator
Odense University Hospital
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 Lung Disease Chronic, run by Odense University Hospital at 1 site in Denmark.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefine Gradman, PhD (0045 29241375, josefine.gradman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: 18 years). The study lists 3 primary outcomes in all. 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 15 Oct 2026.