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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.
Verified March 2013 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 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Asthma
 Device: Standard nebulizer
Device: PARI LC Sprint Sp nebulizer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Length of hospitalization [ Time Frame: hospital discharge (maximum of 10 days) ] [ Designated as safety issue: No ]
    The length of hospitalization in days


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 230
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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

 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649401

Contacts
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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Lucie Gilton-Bott, MD            
Sub-Investigator: Tu Anh Tran, MD            
Sub-Investigator: Sandrine Baron-Joly, MD            
Sub-Investigator: Natacha Catteau, MD            
Sub-Investigator: Gaelle Gauthé, MD            
Sub-Investigator: Philippe Fournier, MD            
Sub-Investigator: Randa Salet, MD            
Sub-Investigator: Carsten Walenda, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Lucie Gilton-Bott, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01649401     History of Changes
Other Study ID Numbers: LOCAL/2012/LG-02, 2012-A00629-34
Study First Received: July 23, 2012
Last Updated: March 26, 2013
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
nebulizer
PARI LC Spring SP

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013