Childhood Asthma With Status AsthmaticusPhase 4STATIC IVNCT03493503
Status Asthmaticus on the PICU; Intravenous Salbutamol
A Phase 4 study testing Salbutamol and Sodium Chloride 0.9% in people with Childhood Asthma With Status Asthmaticus, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Childhood Asthma With Status Asthmaticus
- What is being tested?
- Salbutamol and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Apr 2017to 21 May 2019
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 2-18 years of age at moment of inclusion
- Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
- Requiring administration of IV salbutamol
Who cannot join
- Patient is outside of specified age range
- Patient has already received a -loading dose- of IV salbutamol in the general hospital
- Lower airway infection with consolidation on a chest X ray -Patient has Down's Syndrome
- Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
- Patient has a primary/secondary immunodeficiency
- Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.
- Conditions
- Childhood Asthma With Status Asthmaticus
- Being tested
- Salbutamol, Sodium Chloride 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Intravenous Salbutamol loading dose
Sodium Chloride 0.9%Drug
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol loading dose | Experimental | Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg. Receives: Drug: Salbutamol |
| Sodium Chloride 0.9% | Placebo comparator | 10 ml of Sodium Chloride 0.9% in 10 minutes. Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Asthma score
The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement.
Measured: First 24 hours after admission on the PICU
Secondary outcomes (9)
Cumulative dose of IV salbutamol
Measured: Through study completion, an average 48 hours
Maximum infusion rate of IV salbutamol in mcg/kg/min
Measured: Through study completion, an average 48 hours
Total duration of IV salbutamol treatment in hours
Measured: Through study completion, an average 48 hours
Occurrence/frequency of side effects
Measured: Through study completion, an average 48 hours
Length of Stay on PICU in days
Measured: Through study completion, an average 72 hours
Use of co-medication
Measured: Through study completion, an average 72 hours
Use of/duration of non-invasive mechanical ventilation in days
Measured: Through study completion, an average 72 hours
DNA polymorphism of the ADRB2-receptor gene
The investigators will look at DNA, if there is a polymorphism in the ADRB2-receptor gene. If there is a polymorphism it can cause downregulation of the adrenergic B2 receptors.
Measured: Through study completion, an average 1 year
Use of/duration of non-invasive/invasive mechanical ventilation in days
Measured: Through study completion, an average 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start5 Apr 2017
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Asthma With Status AsthmaticusStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthijs de Hoog, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493503
- Sponsor's protocol ID
- NL55029.078.16
- Acronym
- STATIC IV
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
- ClinicalTrials.gov ID
- NCT03493503
- Acronym / sponsor ID
- STATIC IV / NL55029.078.16
- Conditions
- Childhood Asthma With Status Asthmaticus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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.
Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol loading dose | Experimental | Drug: SalbutamolSalbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg. |
| Sodium Chloride 0.9% | Placebo comparator | Drug: Sodium Chloride 0.9%10 ml of Sodium Chloride 0.9% in 10 minutes. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between 2-18 years of age at moment of inclusion
- Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
- Requiring administration of IV salbutamol
Key exclusion criteria (6 listed)
- Patient is outside of specified age range
- Patient has already received a -loading dose- of IV salbutamol in the general hospital
- Lower airway infection with consolidation on a chest X ray -Patient has Down's Syndrome
- Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
- Patient has a primary/secondary immunodeficiency
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 |
|---|---|---|
| SalbutamolIntravenous Salbutamol loading dose | Drug | Salbutamol loading dose |
| Sodium Chloride 0.9%10 ml of Sodium Chloride 0.9% in 10 minutes intravenous | Drug | Sodium Chloride 0.9% |
Primary outcome
Reduction Asthma score
Time frame: First 24 hours after admission on the PICU
The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement.
9 secondary outcomes
Cumulative dose of IV salbutamol
Time frame: Through study completion, an average 48 hours
Maximum infusion rate of IV salbutamol in mcg/kg/min
Time frame: Through study completion, an average 48 hours
Total duration of IV salbutamol treatment in hours
Time frame: Through study completion, an average 48 hours
Occurrence/frequency of side effects
Time frame: Through study completion, an average 48 hours
Length of Stay on PICU in days
Time frame: Through study completion, an average 72 hours
Use of co-medication
Time frame: Through study completion, an average 72 hours
Use of/duration of non-invasive mechanical ventilation in days
Time frame: Through study completion, an average 72 hours
DNA polymorphism of the ADRB2-receptor gene
Time frame: Through study completion, an average 1 year
Use of/duration of non-invasive/invasive mechanical ventilation in days
Time frame: Through study completion, an average 72 hours
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 30 Jul 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol and Sodium Chloride 0.9% in people with Childhood Asthma With Status Asthmaticus, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 6 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 30 Jul 2020. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction Asthma score (time frame: First 24 hours after admission on the PICU). 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 30 Jul 2020.