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

September 17, 2014 updated by: University Hospital, Rouen
  • 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Pediatric department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cell profiles Analysis regarding the severity of asthma as defined above.
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Christophe MARGUET, Professor, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/056/HP
  • 2009- A00774-53 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infantile Asthma

Clinical Trials on Sputum induction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe