NCT02245074

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

October 15, 2010

Last Update Submit

September 17, 2014

Conditions

Infantile Asthma

Keywords

Infantile asthmaInduced sputumPhenotypesEosinophilsNeutrophils

Outcome Measures

Primary Outcomes (1)

  • Cell profiles Analysis regarding the severity of asthma as defined above.

    Day 1

Study Arms (3)

Acute exacerbation

OTHER

Cell profiles Analysis after sputum induction in infants with Acute exacerbation

Other: Sputum induction

Uncontrolled asthma

OTHER

Cell profiles Analysis after sputum induction in infants with Uncontrolled asthma

Other: Sputum induction

controlled asthma

OTHER

Cell profiles Analysis after sputum induction in infants controlled asthma

Other: Sputum induction

Interventions

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.

Acute exacerbationUncontrolled asthmacontrolled asthma

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Department

Rouen, 76031, France

Location

Study Officials

  • Christophe MARGUET, Professor

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2010

First Posted

September 19, 2014

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

FR(1)