Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction
NCT ID: NCT02245074
Last Updated: 2014-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
34 participants
INTERVENTIONAL
2010-06-30
2012-08-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Acute exacerbation
Cell profiles Analysis after sputum induction in infants with Acute exacerbation
Sputum induction
The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
Uncontrolled asthma
Cell profiles Analysis after sputum induction in infants with Uncontrolled asthma
Sputum induction
The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
controlled asthma
Cell profiles Analysis after sputum induction in infants controlled asthma
Sputum induction
The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
Interventions
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Sputum induction
The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
Eligibility Criteria
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Inclusion Criteria
* Ambulatory or hospitalized.
* With %SaO2 ³ 95%
* Parents information and non-opposition from the parents
Exclusion Criteria
* 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%
6 Months
3 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Christophe MARGUET, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Pediatric Department
Rouen, , France
Countries
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Other Identifiers
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2009- A00774-53
Identifier Type: OTHER
Identifier Source: secondary_id
2009/056/HP
Identifier Type: -
Identifier Source: org_study_id
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