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Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction (CYTOASTHME)

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ClinicalTrials.gov Identifier: NCT02245074
Recruitment Status : Terminated (lack of recruitment)
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Infantile Asthma Other: Sputum induction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Acute exacerbation
Cell profiles Analysis after sputum induction in infants with Acute exacerbation
 Other: 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
 Other: 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
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cell profiles Analysis regarding the severity of asthma as defined above. [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 6 and 36 mo.
  • Ambulatory or hospitalized.
  • With %SaO2 ³ 95%
  • Parents information and non-opposition from the parents

Exclusion Criteria:

  • 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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245074


Locations
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France
Pediatric Department
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Christophe MARGUET, Professor University Hospital, Rouen
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02245074    
Other Study ID Numbers: 2009/056/HP
2009- A00774-53 ( Other Identifier: AFSSAPS )
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by University Hospital, Rouen:
Infantile asthma
Induced sputum
Phenotypes
Eosinophils
Neutrophils
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes