AsthmaLC SPRINT SpNCT01649401
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
A study testing Standard nebulizer and PARI LC Sprint Sp nebulizer in people with Asthma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Asthma
- What is being tested?
- Standard nebulizer and PARI LC Sprint Sp nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to 4 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma
- Being tested
- Standard nebulizer, PARI LC Sprint Sp nebulizer
- Keywords
- nebulizer, PARI LC Spring SP
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard nebulizerDevice
Also called Micro Mist Nebulizer
Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
PARI LC Sprint Sp nebulizerDevice
Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.
Manufacturer: PARI GmbH Germany
| Study group | Role | What they receive |
|---|---|---|
| Standard nubulizer | Active comparator | 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. Receives: Device: Standard nebulizer |
| Experimental nebulizer | Experimental | Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer.
Manufacturer: PARI GmbH Germany Receives: Device: PARI LC Sprint Sp nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
The length of hospitalization in days
Measured: hospital discharge (maximum of 10 days)
Secondary outcomes (46)
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
Measured: Day 0
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 0
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 0
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)
Measured: Day 0
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
Measured: Day 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
Measured: Day 2
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
Measured: Day 3
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
Measured: Day 4
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
Measured: Day 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
Measured: Day 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
Measured: Day 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
Measured: Day 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
Measured: Day 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
Measured: Day 10
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 1
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 2
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 3
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 4
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 5
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 6
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 7
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 8
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 9
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Measured: Day 10
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 1
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 2
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 3
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 4
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 5
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 6
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 7
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 8
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 9
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Measured: Day 10
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)
Measured: Day 1
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)
Measured: Day 2
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)
Measured: Day 3
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)
Measured: Day 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)
Measured: Day 5
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)
Measured: Day 6
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)
Measured: Day 7
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)
Measured: Day 8
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)
Measured: Day 9
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)
Measured: Day 10
Parent estimated tolerance
A visual analog scale is used to evaluate how parents estimate aerosol tolerance.
Measured: Hospital discharge (maximum 10 days)
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
Measured: Hospital discharge (maximum 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startDec 2012
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie Gilton-Bott, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649401
- Sponsor's protocol ID
- LOCAL/2012/LG-02
- Other IDs
- 2012-A00629-34
- Acronym
- LC SPRINT Sp
- Status last verified
- Jan 2017
- First submitted
- 23 Jul 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
- ClinicalTrials.gov ID
- NCT01649401
- Acronym / sponsor ID
- LC SPRINT Sp / LOCAL/2012/LG-02
- Conditions
- Asthma
- Keywords
- nebulizer, PARI LC Spring SP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard nubulizer | Active comparator | Device: Standard nebulizerNebulizer 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 nebulizer | Experimental | Device: PARI LC Sprint Sp nebulizerNebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard nebulizerAlso: Micro Mist NebulizerNebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical. | Device | Standard nubulizer |
| PARI LC Sprint Sp nebulizerNebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany | Device | Experimental nebulizer |
Primary outcome
Length of hospitalization
Time frame: hospital discharge (maximum of 10 days)
The length of hospitalization in days
46 secondary outcomes
Duration of oxygen therapy
Time frame: Day 0
Heart rate before the first nebulisation session
Time frame: Day 0
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 0
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 0
Duration of oxygen therapy
Time frame: Day 1
Duration of oxygen therapy
Time frame: Day 2
Duration of oxygen therapy
Time frame: Day 3
Duration of oxygen therapy
Time frame: Day 4
Duration of oxygen therapy
Time frame: Day 5
Duration of oxygen therapy
Time frame: Day 6
Duration of oxygen therapy
Time frame: Day 7
Duration of oxygen therapy
Time frame: Day 8
Duration of oxygen therapy
Time frame: Day 9
Duration of oxygen therapy
Time frame: Day 10
Heart rate before the first nebulisation session
Time frame: Day 1
Heart rate before the first nebulisation session
Time frame: Day 2
Heart rate before the first nebulisation session
Time frame: Day 3
Heart rate before the first nebulisation session
Time frame: Day 4
Heart rate before the first nebulisation session
Time frame: Day 5
Heart rate before the first nebulisation session
Time frame: Day 6
Heart rate before the first nebulisation session
Time frame: Day 7
Heart rate before the first nebulisation session
Time frame: Day 8
Heart rate before the first nebulisation session
Time frame: Day 9
Heart rate before the first nebulisation session
Time frame: Day 10
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 1
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 2
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 3
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 4
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 5
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 6
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 7
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 8
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 9
Heart rate 30 minutes after the first nebulisation session
Time frame: Day 10
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 1
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 2
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 3
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 4
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 5
SpO2 saturation less thant 90% during or after nebulisation session?
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Gilton-Bott, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard nebulizer and PARI LC Sprint Sp nebulizer in people with Asthma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospitalization (time frame: hospital discharge (maximum of 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.