Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age (LC SPRINT Sp)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01649401
First received: July 23, 2012
Last updated: March 4, 2014
Last verified: March 2014

July 23, 2012
March 4, 2014
December 2012
October 2015   (final data collection date for primary outcome measure)
Length of hospitalization [ Time Frame: hospital discharge (maximum of 10 days) ] [ Designated as safety issue: No ]
The length of hospitalization in days
Same as current
Complete list of historical versions of study NCT01649401 on ClinicalTrials.gov Archive Site
  • Duration of oxygen therapy [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Heart rate before the first nebulisation session [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • Duration of oxygen therapy [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Duration of oxygen therapy [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
  • Heart rate before the first nebulisation session [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate before the first nebulisation session [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Heart rate before the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Heart rate 30 minutes after the first nebulisation session (bpm)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
  • Parent estimated tolerance [ Time Frame: Hospital discharge (maximum 10 days) ] [ Designated as safety issue: No ]
    A visual analog scale is used to evaluate how parents estimate aerosol tolerance.
  • Length of hospitalization according to discharge criteria [ Time Frame: Hospital discharge (maximum 10 days) ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • 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.
    Other Name: Micro Mist Nebulizer
  • 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

    Other Name: PARI LC Sprint Sp nebulizer
  • 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.
    Intervention: Device: Standard nebulizer
  • 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

    Intervention: Device: PARI LC Sprint Sp nebulizer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
6 Months to 36 Months
No
Contact: Lucie Gilton-Bott, MD +33.(0)4.66.32.84 lucie.gilton.bott@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr
France
 
NCT01649401
LOCAL/2012/LG-02, 2012-A00629-34
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Lucie Gilton-Bott, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP