Infantile AsthmaCYTOASTHMENCT02245074
Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction
A study testing Sputum induction in people with Infantile Asthma, run by University Hospital, Rouen at 1 site in France.
Trial summary
Background: Infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. Namely, the infants could be classified as transitory, peristent or late and persistent asthma. Some risk factors for the persistent asthma phenotype are recognized as atopy. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Infantile Asthma
- What is being tested?
- Sputum induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Aug 2012
- 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 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 and 36 mo.
- Ambulatory or hospitalized.
- With %SaO2 ³ 95%
- Parents information and non-opposition from the parents
Who cannot join
- Any underlying chronic disease
- Been given oral corticosteroid during the last four weeks
- Known adverse events with nebulized saline solution
- With cold during the 4 last weeks for the controled group.
- With %SaO2 < 95%
Trial locations and contacts
1 site in 1 country.
About this study
- Background: Infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. Namely, the infants could be classified as transitory, peristent or late and persistent asthma. Some risk factors for the persistent asthma phenotype are recognized as atopy. However all peristent asthma are not related to atopy. Regarding the pathophysiology, little is known on airways inflammation in these infants, and the current data are mostly based on the BAL analyses, or on biopsies. Consequently, BLA and biopsies should be justified by the need of an indicated fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion could be also collected after hypertonic saline induction and chest physiotherapy. This method has been validated in the children, but has not in the younger.
- Aim : Analyses of cell profiles regarding the severity of infantile asthma.
- Methods : This descriptive study compared 3 groups of infants, the first with acute exacerbation, the second with uncontrolled asthma and the third with controlled asthma. Accounting 25% of failure, the number of 40 infants per groups has been calculated. The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended. Safety will be evaluated.
- Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of wheezing during the 2 first years of life), aged between 6-12months.Asthma control was evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled asthma was defined whether the infant presented any symptoms during the last 4 weeks. Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.
- Feasibility : A preliminary study has been presented in the Vienna ERS congress.
- Conditions
- Infantile Asthma
- Being tested
- Sputum induction
- Keywords
- Infantile asthma, Induced sputum, Phenotypes, Eosinophils, Neutrophils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum inductionOther
The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
| Study group | Role | What they receive |
|---|---|---|
| Acute exacerbation | Other | Cell profiles Analysis after sputum induction in infants with Acute exacerbation Receives: Other: Sputum induction |
| Uncontrolled asthma | Other | Cell profiles Analysis after sputum induction in infants with Uncontrolled asthma Receives: Other: Sputum induction |
| controlled asthma | Other | Cell profiles Analysis after sputum induction in infants controlled asthma Receives: Other: Sputum induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell profiles Analysis regarding the severity of asthma as defined above.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionAug 2012
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MARGUET, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245074
- Sponsor's protocol ID
- 2009/056/HP
- Other IDs
- 2009- A00774-53
- Acronym
- CYTOASTHME
- Status last verified
- Sep 2014
- First submitted
- 15 Oct 2010
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction
- ClinicalTrials.gov ID
- NCT02245074
- Acronym / sponsor ID
- CYTOASTHME / 2009/056/HP
- Conditions
- Infantile Asthma
- Keywords
- Infantile asthma, Induced sputum, Phenotypes, Eosinophils, Neutrophils
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Sep 2014 (estimated)
- 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.
- Background: Infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. Namely, the infants could be classified as transitory, peristent or late and persistent asthma. Some risk factors for the persistent asthma phenotype are recognized as atopy. However all peristent asthma are not related to atopy. Regarding the pathophysiology, little is known on airways inflammation in these infants, and the current data are mostly based on the BAL analyses, or on biopsies. Consequently, BLA and biopsies should be justified by the need of an indicated fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion could be also collected after hypertonic saline induction and chest physiotherapy. This method has been validated in the children, but has not in the younger.
- Aim : Analyses of cell profiles regarding the severity of infantile asthma.
- Methods : This descriptive study compared 3 groups of infants, the first with acute exacerbation, the second with uncontrolled asthma and the third with controlled asthma. Accounting 25% of failure, the number of 40 infants per groups has been calculated. The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended. Safety will be evaluated.
- Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of wheezing during the 2 first years of life), aged between 6-12months.Asthma control was evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled asthma was defined whether the infant presented any symptoms during the last 4 weeks. Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.
- Feasibility : A preliminary study has been presented in the Vienna ERS congress.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute exacerbation | Other | Other: Sputum inductionCell profiles Analysis after sputum induction in infants with Acute exacerbation |
| Uncontrolled asthma | Other | Other: Sputum inductionCell profiles Analysis after sputum induction in infants with Uncontrolled asthma |
| controlled asthma | Other | Other: Sputum inductionCell profiles Analysis after sputum induction in infants controlled asthma |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 6 and 36 mo.
- Ambulatory or hospitalized.
- With %SaO2 ³ 95%
- Parents information and non-opposition from the parents
Key exclusion criteria (5 listed)
- Any underlying chronic disease
- Been given oral corticosteroid during the last four weeks
- Known adverse events with nebulized saline solution
- With cold during the 4 last weeks for the controled group.
- With %SaO2 < 95%
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 |
|---|---|---|
| Sputum inductionThe sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended. | Other | Acute exacerbation, Uncontrolled asthma, controlled asthma |
Primary outcome
Cell profiles Analysis regarding the severity of asthma as defined above.
Time frame: Day 1
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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.
Christophe MARGUET, Professor principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum induction in people with Infantile Asthma, run by University Hospital, Rouen 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Sep 2014. 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?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Cell profiles Analysis regarding the severity of asthma as defined above. (time frame: Day 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 19 Sep 2014.