Acute BronchiolitisNCT03915197
Acute Bronchiolitis in Infants and Allergic Asthma
A study testing Pneumological evaluation in people with Acute Bronchiolitis and Asthma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult. Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory… Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Acute Bronchiolitis, Asthma, Allergy
- What is being tested?
- Pneumological evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 30 Oct 2023
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.
Who cannot join
- Bronchopulmonary dysplasia;
- History of prematurity <34 AS;
- Mucoviscidosis;
- known immune deficiencies;
- Primary ciliary dyskinesia suspected;
- Congenital heart disease;
- Acute renal failure.
- Refusal of parents to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, promo_interne_drci@chu-clermontferrand.fr
André LABBE
About this study
Official title: Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term
Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.
Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.
Read the detailed description
Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:
- Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;
- Physical examination ;
- Evaluation of precariousness during the same interview with the EPICES questionnaire;
- Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);
- Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;
- Fonctionnal respiratory test with reversibility test
- Conditions
- Acute Bronchiolitis, Asthma, Allergy
- Being tested
- Pneumological evaluation
- Keywords
- allergic asthma, acute bronchiolitis, allergic sensitization, -risk factor
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumological evaluationDiagnostic test
Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | cohorts of infants with acute bronchiolitis Receives: Diagnostic Test: Pneumological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for asthma 6 years after an episode of acute bronchiolitis
Presence / absence of asthma 6-9 years after an episode of bronchiolitis during the first year of life
The diagnosis of asthma is established during a consultation by a pneumopediatrician on the following criteria:
- ≥3 documented respiratory symptoms ≥ 2 times;
- Or an episode lasting ≥ 4 weeks;
- With symptoms: tachypnea, wheezing, expiratory stridor, signs of chest retraction or wheezing diagnosed by a doctor.
Measured: at 6 years
Secondary outcomes (4)
Correlation between onset of asthma and severity of bronchiolitis
Severity of acute bronchiolitis, assessed by a clinical score based on control signs, spO2 and respiratory rate (Wainwright score) and the length of hospital stay
Measured: at 6 years
relationship between KL-6 serum markers and the occurrence of longer-term asthma
Correlation between onset of asthma and concentration of KL-6 during bronchiolitis
Measured: at 6 years
relationship between CC16 serum markers and the occurrence of longer-term asthma
Correlation between onset of asthma and concentration of CC16 during bronchiolitis.
Measured: at 6 years
relationship between sRAGE serum markers and the occurrence of longer-term asthma
Correlation between onset of asthma and concentration of sRAGE during bronchiolitis
Measured: at 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start2 May 2019 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André LABBE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915197
- Sponsor's protocol ID
- CHU-433
- Other IDs
- 2018-A02659-46
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term
- ClinicalTrials.gov ID
- NCT03915197
- Acronym / sponsor ID
- CHU-433
- Conditions
- Acute Bronchiolitis, Asthma, Allergy
- Keywords
- allergic asthma, acute bronchiolitis, allergic sensitization, -risk factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 May 2019 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 16 Apr 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.
Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.
Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.
Detailed description
Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:
- Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;
- Physical examination ;
- Evaluation of precariousness during the same interview with the EPICES questionnaire;
- Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);
- Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;
- Fonctionnal respiratory test with reversibility test
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Diagnostic Test: Pneumological evaluationcohorts of infants with acute bronchiolitis |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.
Key exclusion criteria (8 listed)
- Bronchopulmonary dysplasia;
- History of prematurity <34 AS;
- Mucoviscidosis;
- known immune deficiencies;
- Primary ciliary dyskinesia suspected;
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 |
|---|---|---|
| Pneumological evaluationConsultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking | Diagnostic test | group 1 |
Primary outcome
Risk factors for asthma 6 years after an episode of acute bronchiolitis
Time frame: at 6 years
Presence / absence of asthma 6-9 years after an episode of bronchiolitis during the first year of life The diagnosis of asthma is established during a consultation by a pneumopediatrician on the following criteria: * ≥3 documented respiratory symptoms ≥ 2 times; * Or an episode lasting ≥ 4 weeks; * With symptoms: tachypnea, wheezing, expiratory stridor, signs of chest retraction or wheezing diagnosed by a doctor.
4 secondary outcomes
Correlation between onset of asthma and severity of bronchiolitis
Time frame: at 6 years
relationship between KL-6 serum markers and the occurrence of longer-term asthma
Time frame: at 6 years
relationship between CC16 serum markers and the occurrence of longer-term asthma
Time frame: at 6 years
relationship between sRAGE serum markers and the occurrence of longer-term asthma
Time frame: at 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
André LABBE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumological evaluation in people with Acute Bronchiolitis and Asthma, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 8 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 16 Apr 2019. 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 Lise LACLAUTRE (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for asthma 6 years after an episode of acute bronchiolitis (time frame: at 6 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 16 Apr 2019.