Asthma in ChildrenARISENCT05419622
Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn
A study testing bronchial biopsies in people with Asthma in Children, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
This study is a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with severe asthma. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- bronchial biopsies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jun 2023to 30 Aug 2025
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child from 6 to 17 years old
- Having informed consent signed by the holders of parental authority.
- Having a diagnosis of severe asthma according to the Global Initiative for Asthma (GINA) 2020;
- Asthma: chronic inflammatory disease of the airways, defined mainly by respiratory symptoms such as wheezing, dyspnea, chest tightness and / or cough, which may vary in time and intensity associated with a limitation also varying in the time of expiratory flow.
- Severe asthma: asthma which requires treatment with inhaled corticosteroids in high doses plus a second long-acting bronchodilator type controller, to maintain control of symptoms and / or whose control worsens if this treatment is reduced and / or which remains uncontrolled despite this treatment.
- Having to carry out as part of the current care a functional respiratory exploration;
- Should require as part of the routine care of a bronchial fibroscopy.
Who cannot join
- Patient without affiliation or not benefiting from a social security scheme;
- Patient being in a period of relative exclusion from another protocol;
- Patient born before 36 weeks of amenorrhea;
- Patient with a documented history of pulmonary fibrosis, primary pulmonary arterial hypertension, cystic fibrosis, pulmonary malformation or chronic viral infections (hepatitis, HIV);
- Patient presenting with an exacerbation of asthma requiring systemic corticosteroids within the previous 4 weeks;
- Patient with any dental, nasopharyngeal or bronchial infection with fever (> 39 ° C) requiring systemic antibiotics within the previous 4 weeks
Show all 14Show fewer
- Patient with a contraindication to MRI:
- Abdominal perimeter greater than 200 cm;
- Claustrophobia or inability to lie still for 12 minutes;
- Have a pacemaker or implantable defibrillator, intraocular metallic foreign body, intracranial metal clip, a pre-6000 Starr-Edwards type heart valve prosthesis, or a biomedical device such as an insulin pump or neurostimulator, cochlear implant and metal patch.
- Patient with a contraindication to anesthesia;
- Patient with a contraindication to bronchial fibroscopy following:
- Abnormal hemostasis assessment;
- Subject with cardiac pathology.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Bordeaux - Explorations Fonctionnelles
Bordeaux, 33000
Fabien BEAUFILS, MD, +335 56 79 55 86, fabien.beaufils@chu-bordeaux.fr
Mickael FAYON, MD,PhD
- Not yet recruiting
Centre Hospitalier de Saintonge
Saintes, 17100
Céline NOBILI-DUBARRY, MD, +335 46 95 15 07, c.nobili-dubarry@ch-saintonge.fr
Céline NOBILI-DUBARRY, MD
About this study
This study is a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with severe asthma. The primary objective is to compare bronchial parameters measured by 3D-UTE MRI according to the presence or the absence of bronchial remodeling determined on bronchial biopsies using immunohistochemistry, in severe asthmatic children.
Read the detailed description
Background: Asthma is the most frequent chronic disease in childhood. Severe asthma accounts for only 5% of patients but more than half of the costs of the disease. It is characterized by bronchial remodeling, including an increase in bronchial smooth muscle (BSM) mass associated with an increase in bronchial smooth muscle cell proliferation. This increased cell proliferation has been related with an abnormal calcium homeostasis and an enhanced mitochondrial biogenesis. Moreover, the release of growth factors by inflammatory cells and bronchial epithelial cells reinforces BSM cell proliferation. BSM remodeling is correlated with the severity and poor control of the disease. In children, bronchial remodeling could be assessed by performing endobronchial biopsies during bronchoscopy. However, this method is invasive and cannot be repeated to follow the remodeling. Non-invasive quantification of proximal bronchial thickness by computed tomography (CT) has been demonstrated. However, CT was unable to differentiate bronchial inflammation from remodeling on the one hand, and, on the other hand, CT is a radiating examination, and the repetition of X-ray exposures can be a source of cancer. Recently, the team evaluated at the university hospital of Bordeaux new MRI sequences to obtain 3D high-resolution images (3D-UTE), close to that of CT. This 3D-UTE has the advantage of being performed without any injection or inhalation of contrast medium and non-irradiating. Moreover, MRI provides additional data on signal intensity or bronchial inflammation that is not accessible on CT imaging. However, to the best of our knowledge, the use of 3D -UTE high resolution MRI has not been demonstrated in a pediatric population with severe asthma.
Purpose: To compare bronchial parameters measured in 3D-UTE MRI according to the presence or not of bronchial remodeling measured by immunohistochemistry on bronchial biopsies obtained from severe asthmatic children.
Methods: The investigator's team therefore wishes to carry out pulmonary MRI without anesthesia, nor injection nor inhalation of contrast product in severe asthmatic children. Two sequences in axial cuts will be performed for a total duration of 12 minutes (6 minutes by sequence). Bronchial quantitative data obtained by MRI will be compared to those obtained from immunohistochemical analysis of bronchial biopsies performed during bronchoscopy. Severe asthmatic children requiring bronchoscopy will be identified during consultation or hospitalization relative of the disease. The inclusion visit (V1) will be performed during a consultation for asthma of the usual care of the child. Then, the second visit (V2) will correspond to the anesthesia consultation of the usual care of the child to check the absence of contraindications to anesthesia and bronchoscopy. The third visit (V3) will correspond to the pulmonary MRI and flexible bronchoscopy. According to the classic procedure, bronchoscopy will be performed during a hospitalization. The pulmonary MRI, as well as blood tests and lung function testing, will be performed at the beginning of the hospitalization, the day before the bronchoscopy. Children will be monitored 24 hours in hospitalization after the bronchoscopy.
- Conditions
- Asthma in Children
- Being tested
- bronchial biopsies
- Keywords
- asthma, children, serious, magnetic resonance imaging
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial biopsiesBiological
This fibroscopy will make it possible to perform 4 bronchial biopsies at the level of the 4th bronchial generation (subsegmental bronchi), using suitable pediatric forceps.
| Study group | Role | What they receive |
|---|---|---|
| lung MRI | Experimental | The procedure under study is lung MRI, performed on a 1.5T magnet (AERA dot 1.5T, Siemens), without anesthesia and without injection or inhalation of contrast agent. Receives: Biological: bronchial biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Bronchial thickness (BT) in UTE-T1 (in mm)
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3:
- Bronchial thickness (BT) in UTE-T1 (mm)
Measured: Day 30
Measure of Signal strength of the bronchial wall (SB) in UTE-T1 (in milliseconds)
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3:
- Signal intensity of bronchial edema (SE) in T2- Turbo Spin-Echo (TSE) (second)
Measured: Day 30
Measure of Volume of bronchial edema (VO) in T2-Turbo Spin-Echo (TSE) (in cubic millimeters)
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3:
- Volume of bronchial edema (VE) in T2-Turbo Spin-Echo (TSE) (mm^3)
Measured: Day 30
Measure of Bronchial edema (SO) signal intensity in T2-Turbo Spin-Echo (TSE) (in milliseconds)
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3:
- Signal intensity of bronchial edema (SE) in T2-Turbo Spin-Echo (TSE) (second)
Measured: Day 30
Secondary outcomes (8)
Comparison each measurable values between 2 Physicians evaluated in the principal outcome measures
Intra-and inter-observer intraclass correlation coefficients of each of the parameters measured in 3D-UTE MRI, with their 95% confidence interval, and graphic representation of Bland and Altman
Measured: Day 30
Measure of expiratory forced vital capacity (FVC)
Functional respiratory data
Measured: Day 30
Measure of forced expiratory volume in one second (FEV1)
Functional respiratory data
Measured: Day 30
Measure length of reticular basement membrane (RBM) completely denuded or covered by a single layer of basal cells with no intact ciliated or goblet cell over total basement membrane length
Values measured by immunohistochemistry to assess epithelial integrity in percent.
Measured: Day 30
Measure of reticular basement membrane thickness (µm)
Values measured by immunohistochemistry
Measured: Day 30
Measure of density of blood vessels (number/cm²)
Values measured by immunohistochemistry
Measured: Day 30
Measure of normalized fibrosis area (%)
Values measured by immunohistochemistry
Measured: Day 30
Measure of reticular basement membrane to bronchial smooth muscle distance (µm)
Values measured by immunohistochemistry
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start8 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Early study to evaluate the diagnostic and diagnostic performances of an imaging sequence, non-randomized, observational, prospective and bicentric.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien BEAUFILS, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419622
- Sponsor's protocol ID
- CHUBX 2020/48
- Acronym
- ARISE
- Status last verified
- Jun 2023
- First submitted
- 11 May 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bara I, Ozier A, Tunon de Lara JM, Marthan R, Berger P. Pathophysiology of bronchial smooth muscle remodelling in asthma. Eur Respir J. 2010 Nov;36(5):1174-84. doi: 10.1183/09031936.00019810.
PubMed 21037369Girodet PO, Ozier A, Bara I, Tunon de Lara JM, Marthan R, Berger P. Airway remodeling in asthma: new mechanisms and potential for pharmacological intervention. Pharmacol Ther. 2011 Jun;130(3):325-37. doi: 10.1016/j.pharmthera.2011.02.001. Epub 2011 Feb 17.
PubMed 21334378Bossley CJ, Fleming L, Gupta A, Regamey N, Frith J, Oates T, Tsartsali L, Lloyd CM, Bush A, Saglani S. Pediatric severe asthma is characterized by eosinophilia and remodeling without T(H)2 cytokines. J Allergy Clin Immunol. 2012 Apr;129(4):974-82.e13. doi: 10.1016/j.jaci.2012.01.059. Epub 2012 Mar 3.
PubMed 22385633Benlala I, Dournes G, Girodet PO, Benkert T, Laurent F, Berger P. Evaluation of bronchial wall thickness in asthma using magnetic resonance imaging. Eur Respir J. 2021 Dec 31;59(1):2100329. doi: 10.1183/13993003.00329-2021. Print 2022 Jan. No abstract available.
PubMed 34049945Dournes G, Yazbek J, Benhassen W, Benlala I, Blanchard E, Truchetet ME, Macey J, Berger P, Laurent F. 3D ultrashort echo time MRI of the lung using stack-of-spirals and spherical k-Space coverages: Evaluation in healthy volunteers and parenchymal diseases. J Magn Reson Imaging. 2018 Dec;48(6):1489-1497. doi: 10.1002/jmri.26212. Epub 2018 Sep 11.
PubMed 30203889
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn
- ClinicalTrials.gov ID
- NCT05419622
- Acronym / sponsor ID
- ARISE / CHUBX 2020/48
- Conditions
- Asthma in Children
- Keywords
- asthma, children, serious, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Jun 2022 (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 a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with severe asthma. The primary objective is to compare bronchial parameters measured by 3D-UTE MRI according to the presence or the absence of bronchial remodeling determined on bronchial biopsies using immunohistochemistry, in severe asthmatic children.
Detailed description
Background: Asthma is the most frequent chronic disease in childhood. Severe asthma accounts for only 5% of patients but more than half of the costs of the disease. It is characterized by bronchial remodeling, including an increase in bronchial smooth muscle (BSM) mass associated with an increase in bronchial smooth muscle cell proliferation. This increased cell proliferation has been related with an abnormal calcium homeostasis and an enhanced mitochondrial biogenesis. Moreover, the release of growth factors by inflammatory cells and bronchial epithelial cells reinforces BSM cell proliferation. BSM remodeling is correlated with the severity and poor control of the disease. In children, bronchial remodeling could be assessed by performing endobronchial biopsies during bronchoscopy. However, this method is invasive and cannot be repeated to follow the remodeling. Non-invasive quantification of proximal bronchial thickness by computed tomography (CT) has been demonstrated. However, CT was unable to differentiate bronchial inflammation from remodeling on the one hand, and, on the other hand, CT is a radiating examination, and the repetition of X-ray exposures can be a source of cancer. Recently, the team evaluated at the university hospital of Bordeaux new MRI sequences to obtain 3D high-resolution images (3D-UTE), close to that of CT. This 3D-UTE has the advantage of being performed without any injection or inhalation of contrast medium and non-irradiating. Moreover, MRI provides additional data on signal intensity or bronchial inflammation that is not accessible on CT imaging. However, to the best of our knowledge, the use of 3D -UTE high resolution MRI has not been demonstrated in a pediatric population with severe asthma.
Purpose: To compare bronchial parameters measured in 3D-UTE MRI according to the presence or not of bronchial remodeling measured by immunohistochemistry on bronchial biopsies obtained from severe asthmatic children.
Methods: The investigator's team therefore wishes to carry out pulmonary MRI without anesthesia, nor injection nor inhalation of contrast product in severe asthmatic children. Two sequences in axial cuts will be performed for a total duration of 12 minutes (6 minutes by sequence). Bronchial quantitative data obtained by MRI will be compared to those obtained from immunohistochemical analysis of bronchial biopsies performed during bronchoscopy. Severe asthmatic children requiring bronchoscopy will be identified during consultation or hospitalization relative of the disease. The inclusion visit (V1) will be performed during a consultation for asthma of the usual care of the child. Then, the second visit (V2) will correspond to the anesthesia consultation of the usual care of the child to check the absence of contraindications to anesthesia and bronchoscopy. The third visit (V3) will correspond to the pulmonary MRI and flexible bronchoscopy. According to the classic procedure, bronchoscopy will be performed during a hospitalization. The pulmonary MRI, as well as blood tests and lung function testing, will be performed at the beginning of the hospitalization, the day before the bronchoscopy. Children will be monitored 24 hours in hospitalization after the bronchoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Early study to evaluate the diagnostic and diagnostic performances of an imaging sequence, non-randomized, observational, prospective and bicentric.
| Arm | Type | Receives |
|---|---|---|
| lung MRI | Experimental | Biological: bronchial biopsiesThe procedure under study is lung MRI, performed on a 1.5T magnet (AERA dot 1.5T, Siemens), without anesthesia and without injection or inhalation of contrast agent. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child from 6 to 17 years old
- Having informed consent signed by the holders of parental authority.
- Having a diagnosis of severe asthma according to the Global Initiative for Asthma (GINA) 2020;
- Having to carry out as part of the current care a functional respiratory exploration;
- Should require as part of the routine care of a bronchial fibroscopy.
Key exclusion criteria (14 listed)
- Patient without affiliation or not benefiting from a social security scheme;
- Patient being in a period of relative exclusion from another protocol;
- Patient born before 36 weeks of amenorrhea;
- Patient with a documented history of pulmonary fibrosis, primary pulmonary arterial hypertension, cystic fibrosis, pulmonary malformation or chronic viral infections (hepatitis, HIV);
- Patient presenting with an exacerbation of asthma requiring systemic corticosteroids within the previous 4 weeks;
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 |
|---|---|---|
| bronchial biopsiesThis fibroscopy will make it possible to perform 4 bronchial biopsies at the level of the 4th bronchial generation (subsegmental bronchi), using suitable pediatric forceps. | Biological | lung MRI |
Primary outcome
Measure of Bronchial thickness (BT) in UTE-T1 (in mm)
Time frame: Day 30
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: - Bronchial thickness (BT) in UTE-T1 (mm)
Measure of Signal strength of the bronchial wall (SB) in UTE-T1 (in milliseconds)
Time frame: Day 30
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: - Signal intensity of bronchial edema (SE) in T2- Turbo Spin-Echo (TSE) (second)
Measure of Volume of bronchial edema (VO) in T2-Turbo Spin-Echo (TSE) (in cubic millimeters)
Time frame: Day 30
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: - Volume of bronchial edema (VE) in T2-Turbo Spin-Echo (TSE) (mm^3)
Measure of Bronchial edema (SO) signal intensity in T2-Turbo Spin-Echo (TSE) (in milliseconds)
Time frame: Day 30
Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: - Signal intensity of bronchial edema (SE) in T2-Turbo Spin-Echo (TSE) (second)
8 secondary outcomes
Comparison each measurable values between 2 Physicians evaluated in the principal outcome measures
Time frame: Day 30
Measure of expiratory forced vital capacity (FVC)
Time frame: Day 30
Measure of forced expiratory volume in one second (FEV1)
Time frame: Day 30
Measure length of reticular basement membrane (RBM) completely denuded or covered by a single layer of basal cells with no intact ciliated or goblet cell over total basement membrane length
Time frame: Day 30
Measure of reticular basement membrane thickness (µm)
Time frame: Day 30
Measure of density of blood vessels (number/cm²)
Time frame: Day 30
Measure of normalized fibrosis area (%)
Time frame: Day 30
Measure of reticular basement membrane to bronchial smooth muscle distance (µm)
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Results publication: PubMed 21037369Bara I, Ozier A, Tunon de Lara JM, Marthan R, Berger P. Pathophysiology of bronchial smooth muscle remodelling in asthma. Eur Respir J. 2010 Nov;36(5):1174-84. doi: 10.1183/09031936.00019810.
- Results publication: PubMed 21334378Girodet PO, Ozier A, Bara I, Tunon de Lara JM, Marthan R, Berger P. Airway remodeling in asthma: new mechanisms and potential for pharmacological intervention. Pharmacol Ther. 2011 Jun;130(3):325-37. doi: 10.1016/j.pharmthera.2011.02.001. Epub 2011 Feb 17.
- Results publication: PubMed 22385633Bossley CJ, Fleming L, Gupta A, Regamey N, Frith J, Oates T, Tsartsali L, Lloyd CM, Bush A, Saglani S. Pediatric severe asthma is characterized by eosinophilia and remodeling without T(H)2 cytokines. J Allergy Clin Immunol. 2012 Apr;129(4):974-82.e13. doi: 10.1016/j.jaci.2012.01.059. Epub 2012 Mar 3.
- Results publication: PubMed 34049945Benlala I, Dournes G, Girodet PO, Benkert T, Laurent F, Berger P. Evaluation of bronchial wall thickness in asthma using magnetic resonance imaging. Eur Respir J. 2021 Dec 31;59(1):2100329. doi: 10.1183/13993003.00329-2021. Print 2022 Jan. No abstract available.
- Results publication: PubMed 30203889Dournes G, Yazbek J, Benhassen W, Benlala I, Blanchard E, Truchetet ME, Macey J, Berger P, Laurent F. 3D ultrashort echo time MRI of the lung using stack-of-spirals and spherical k-Space coverages: Evaluation in healthy volunteers and parenchymal diseases. J Magn Reson Imaging. 2018 Dec;48(6):1489-1497. doi: 10.1002/jmri.26212. Epub 2018 Sep 11.
- 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.
Fabien BEAUFILS, MD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial biopsies in people with Asthma in Children, run by University Hospital, Bordeaux at 2 sites 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 7 inclusion and 14 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 9 Jun 2023. 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 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 Fabien BEAUFILS, MD (+335 56 79 55 86, fabien.beaufils@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Bronchial thickness (BT) in UTE-T1 (in mm) (time frame: Day 30). The study lists 4 primary outcomes in all. 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 NCT05419622, which also lists 5 linked publications.
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 9 Jun 2023.