Brief Summary

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Official Title: "Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age"

The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: July 2013

Detailed Clinical Trial Description

The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in:

A-shortened duration of oxygen-dependence.

B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation <90% during the nebulisation sessions.

C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents).

D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep.

Interventions Used in this Clinical Trial

• Device: Standard nebulizer
  • Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
• Device: PARI LC Sprint Sp nebulizer
  • Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Standard nubulizer
  • Nebulizer sessions for the patients in this arm will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
• Experimental: Experimental nebulizer
  • Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Outcome Measures for this Clinical Trial

Primary Measures

• Length of hospitalization
  • Time Frame: hospital discharge (maximum of 10 days)
    Safety Issue?: No

Secondary Measures

• Duration of oxygen therapy
  • Time Frame: Day 0
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 0
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 0
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 0
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 1
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 2
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 3
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 4
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 5
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 6
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 7
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 8
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 9
    Safety Issue?: Yes
• Duration of oxygen therapy
  • Time Frame: Day 10
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 1
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 2
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 3
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 4
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 5
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 6
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 7
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 8
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 9
    Safety Issue?: Yes
• Heart rate before the first nebulisation session
  • Time Frame: Day 10
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 1
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 2
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 3
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 4
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 5
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 6
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 7
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 8
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 9
    Safety Issue?: Yes
• Heart rate 30 minutes after the first nebulisation session
  • Time Frame: Day 10
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 1
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 2
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 3
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 4
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 5
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 6
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 7
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 8
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 9
    Safety Issue?: Yes
• SpO2 saturation less thant 90% during or after nebulisation session?
  • Time Frame: Day 10
    Safety Issue?: Yes
• Parent estimated tolerance
  • Time Frame: Hospital discharge (maximum 10 days)
    Safety Issue?: No
• Length of hospitalization according to discharge criteria
  • Time Frame: Hospital discharge (maximum 10 days)
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• The parent or legal representative must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria:
• requires oxygen: SpO2 <92% on room air (if CAS ≤ 4/10)
• And / or CAS> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care).

Exclusion Criteria

• The patient is participating in another study
• The patients has already been included in this study a previous time
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The parent or legal representative refuses to sign the consent
• It is impossible to correctly inform the parent or legal representative
• The patient has a contra indication for a treatement used in this study
• Patient was born at < 34 weeks of pregnancy or bronchdysplasic
• First or second episode of bronchiolitis
• Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive.
• Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV
• Patient with known congenital heart disease
• Patient with chronic respiratory disease other than asthma
• Patient with encephalopathy
• Patient with known immune deficiency
• CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% when asleep for at least 12h

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 36 Months

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Centre Hospitalier Universitaire de Nīmes
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Lucie Gilton-Bott, MD, Principal Investigator, Centre Hospitalier Universitaire de Nîmes
• Overall Contact(s)
  • Lucie Gilton-Bott, MD, +33.(0)4.66.32.84, lucie.gilton.bott@chu-nimes.fr