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CompletedNCT01649401LC SPRINT SpUpdated Feb 1, 2017

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

An interventional study of Standard nebulizer and PARI LC Sprint Sp nebulizer in Asthma, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
6 Months to 36 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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Keywords

  • nebulizer
  • PARI LC Spring SP
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 110 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceStandard nebulizer

    Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.

    Also known as: Micro Mist Nebulizer

  • DevicePARI LC Sprint Sp nebulizer

    Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

06

What researchers measure

Primary outcomes

  1. Length of hospitalization

    The length of hospitalization in days

    Time frame: hospital discharge (maximum of 10 days)

Secondary outcomes

  1. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 0

  2. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 0

  3. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 0

  4. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 0

  5. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 1

  6. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 2

  7. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 3

  8. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 4

  9. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 5

  10. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 6

  11. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 7

  12. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 8

  13. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 9

  14. Duration of oxygen therapy

    Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours

    Time frame: Day 10

  15. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 1

  16. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 2

  17. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 3

  18. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 4

  19. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 5

  20. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 6

  21. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 7

  22. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 8

  23. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 9

  24. Heart rate before the first nebulisation session

    Heart rate before the first nebulisation session (bpm)

    Time frame: Day 10

  25. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 1

  26. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 2

  27. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 3

  28. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 4

  29. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 5

  30. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 6

  31. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 7

  32. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 8

  33. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 9

  34. Heart rate 30 minutes after the first nebulisation session

    Heart rate 30 minutes after the first nebulisation session (bpm)

    Time frame: Day 10

  35. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 1

  36. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 2

  37. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 3

  38. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 4

  39. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 5

  40. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 6

  41. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 7

  42. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 8

  43. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 9

  44. SpO2 saturation less thant 90% during or after nebulisation session?

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

    Time frame: Day 10

  45. Parent estimated tolerance

    A visual analog scale is used to evaluate how parents estimate aerosol tolerance.

    Time frame: Hospital discharge (maximum 10 days)

  46. Length of hospitalization according to discharge criteria

    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

    Time frame: Hospital discharge (maximum 10 days)

07

Study locations

1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 09, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01649401
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jul 25, 2012
Start date
Dec 2012
Primary completion
Nov 4, 2016
Completion
Nov 4, 2016
Last update
Feb 1, 2017

Study contacts

Lucie Gilton-Bott, MD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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