Infantile Asthma Clinical Trial
— CYTOASTHMEOfficial title:
Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction
- 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.
| Status | Terminated |
| Enrollment | 34 |
| Est. completion date | August 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 3 Years |
| Eligibility |
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% |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Pediatric Department | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cell profiles Analysis regarding the severity of asthma as defined above. | Day 1 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02141893 -
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
|
N/A |