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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01649401
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Asthma Device: Standard nebulizer Device: 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Primary Completion Date : November 4, 2016
Study Completion Date : November 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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



Outcome Measures

Primary Outcome Measures :
  1. Length of hospitalization [ Time Frame: hospital discharge (maximum of 10 days) ]
    The length of hospitalization in days


Secondary Outcome Measures :
  1. Duration of oxygen therapy [ Time Frame: Day 0 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  2. Heart rate before the first nebulisation session [ Time Frame: Day 0 ]
    Heart rate before the first nebulisation session (bpm)

  3. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 0 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  4. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 0 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  5. Duration of oxygen therapy [ Time Frame: Day 1 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  6. Duration of oxygen therapy [ Time Frame: Day 2 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  7. Duration of oxygen therapy [ Time Frame: Day 3 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  8. Duration of oxygen therapy [ Time Frame: Day 4 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  9. Duration of oxygen therapy [ Time Frame: Day 5 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  10. Duration of oxygen therapy [ Time Frame: Day 6 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  11. Duration of oxygen therapy [ Time Frame: Day 7 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  12. Duration of oxygen therapy [ Time Frame: Day 8 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  13. Duration of oxygen therapy [ Time Frame: Day 9 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  14. Duration of oxygen therapy [ Time Frame: Day 10 ]
    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  15. Heart rate before the first nebulisation session [ Time Frame: Day 1 ]
    Heart rate before the first nebulisation session (bpm)

  16. Heart rate before the first nebulisation session [ Time Frame: Day 2 ]
    Heart rate before the first nebulisation session (bpm)

  17. Heart rate before the first nebulisation session [ Time Frame: Day 3 ]
    Heart rate before the first nebulisation session (bpm)

  18. Heart rate before the first nebulisation session [ Time Frame: Day 4 ]
    Heart rate before the first nebulisation session (bpm)

  19. Heart rate before the first nebulisation session [ Time Frame: Day 5 ]
    Heart rate before the first nebulisation session (bpm)

  20. Heart rate before the first nebulisation session [ Time Frame: Day 6 ]
    Heart rate before the first nebulisation session (bpm)

  21. Heart rate before the first nebulisation session [ Time Frame: Day 7 ]
    Heart rate before the first nebulisation session (bpm)

  22. Heart rate before the first nebulisation session [ Time Frame: Day 8 ]
    Heart rate before the first nebulisation session (bpm)

  23. Heart rate before the first nebulisation session [ Time Frame: Day 9 ]
    Heart rate before the first nebulisation session (bpm)

  24. Heart rate before the first nebulisation session [ Time Frame: Day 10 ]
    Heart rate before the first nebulisation session (bpm)

  25. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 1 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  26. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 2 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  27. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 3 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  28. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 4 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  29. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 5 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  30. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 6 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  31. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 7 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  32. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 8 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  33. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 9 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  34. Heart rate 30 minutes after the first nebulisation session [ Time Frame: Day 10 ]
    Heart rate 30 minutes after the first nebulisation session (bpm)

  35. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 1 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  36. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 2 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  37. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 3 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  38. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 4 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  39. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 5 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  40. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 6 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  41. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 7 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  42. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 8 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  43. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 9 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  44. SpO2 saturation less thant 90% during or after nebulisation session? [ Time Frame: Day 10 ]
    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  45. Parent estimated tolerance [ Time Frame: Hospital discharge (maximum 10 days) ]
    A visual analog scale is used to evaluate how parents estimate aerosol tolerance.

  46. Length of hospitalization according to discharge criteria [ Time Frame: Hospital discharge (maximum 10 days) ]
    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 Criteria

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649401


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Lucie Gilton-Bott, MD Centre Hospitalier Universitaire de Nîmes
More Information

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 ( Other Identifier: RCB )
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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