Shortness of BreathPhase 4NCT05667727
The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment Using Improvement PRAM Score as a Primary Outcome
A Phase 4 study testing nebulized epinephrine and Salbutamol in people with Shortness of Breath and Asthma in Children, run by Oman Medical Speciality Board at 1 site in Oman.
Trial summary
Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use
- What is being tested?
- nebulized epinephrine and Salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteOman
- Study dates
- 15 Oct 2023to 1 Jun 2025
- 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 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric age group 3 - 12 years
- known to have asthma
- Initial PRAM Score showed moderate to severe asthma exacerbation
Who cannot join
- History of lung or upper airway disease other than asthma:
- bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects
- History of congenital heart disease or cardiac arrhythmia or heart failure.
- Known hypertension
- Impending respiratory failure (Decreasing mental status, Respiratory fatigue, Impending respiratory arrest, Hypoxemia (pO2 < 60 mmHg), pCO2 could be normal or high)
- Allergy or hypersensitivity to epinephrine
- Patient/Parents refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects.
It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient.
A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.
Read the detailed description
Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size.
Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization.
PRAM score with calculated before and at 60, 80, 100 min after the treatment.
- Conditions
- Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use, Salbutamol Adverse Reaction
- Being tested
- nebulized epinephrine, Salbutamol
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized epinephrineDrug
we are using 1:1000 epinephrine into nebulization form
SalbutamolDrug
Also called The control
Patient will receive salbutamol as 4th nebulization.
| Study group | Role | What they receive |
|---|---|---|
| epinephrine group | Experimental | this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization. Receives: Drug: nebulized epinephrine |
| control group | Active comparator | in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization. Receives: Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pediatric respiratory assessment measure (PRAM) score
treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval.
Measured: at (60) mints
change in pediatric respiratory assessment measure (PRAM) score
immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation.
Measured: at (80) mints
change in pediatric respiratory assessment measure (PRAM) score
immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no.
Total observation will be almost 2 hours in order to look for other outcome as well.
Measured: at (100) mints
Secondary outcomes (5)
Emergency Department (ED) length of stay
"during the assessment", after the exposure
This outcome will be decided upon each reassessment intervals, at any time during assessment if there is no change in PRAM score or worsening patient will receive further treatment as decided before and his enrollment in the study will be ended here.
Measured: from the randomization up to 4 hours
The rate for admission
"during the assessment"
this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.
Measured: from the randomization up to 4 hours
rate of any side effect of nebulized epinephrine
"during the assessment"
Each candidate will be assessed throughout the enrolment in the study, starting from the administration of the medication till 2 hours post exposure.
Measured: from the randomization up to 4 hours
The need for respiratory support (O2, Non-invasive ventilation, intubation)
"during assessment"
Measured: from the randomization to the disposal time
The rate of revisit to Emergency Department within 72 hours of the index visit
"after discharge"
Measured: Till 72 hours post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start15 Oct 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of BreathStudies of the same condition, open and under way.
- 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
- Model description
- both groups will receive salbutamol and ipratropium as back to back nebulization for 3 times. Then the candidate will be randomized into experimental group (epinephrine nebulization) and the control group (salbutamol nebulization as 4th nebulization)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adnan Juma Al Rawahi, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667727
- Sponsor's protocol ID
- R2016
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
- ClinicalTrials.gov ID
- NCT05667727
- Acronym / sponsor ID
- R2016
- Conditions
- Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use, Salbutamol Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 Dec 2022 (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.
Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects.
It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient.
A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.
Detailed description
Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size.
Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization.
PRAM score with calculated before and at 60, 80, 100 min after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- both groups will receive salbutamol and ipratropium as back to back nebulization for 3 times. Then the candidate will be randomized into experimental group (epinephrine nebulization) and the control group (salbutamol nebulization as 4th nebulization)
| Arm | Type | Receives |
|---|---|---|
| epinephrine group | Experimental | Drug: nebulized epinephrinethis arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization. |
| control group | Active comparator | Drug: Salbutamolin this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| nebulized epinephrinewe are using 1:1000 epinephrine into nebulization form | Drug | epinephrine group |
| SalbutamolAlso: The controlPatient will receive salbutamol as 4th nebulization. | Drug | control group |
Primary outcome
change in pediatric respiratory assessment measure (PRAM) score
Time frame: at (60) mints
treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval.
change in pediatric respiratory assessment measure (PRAM) score
Time frame: at (80) mints
immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation.
change in pediatric respiratory assessment measure (PRAM) score
Time frame: at (100) mints
immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no. Total observation will be almost 2 hours in order to look for other outcome as well.
5 secondary outcomes
Emergency Department (ED) length of stay
Time frame: from the randomization up to 4 hours
The rate for admission
Time frame: from the randomization up to 4 hours
rate of any side effect of nebulized epinephrine
Time frame: from the randomization up to 4 hours
The need for respiratory support (O2, Non-invasive ventilation, intubation)
Time frame: from the randomization to the disposal time
The rate of revisit to Emergency Department within 72 hours of the index visit
Time frame: Till 72 hours post discharge
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 6 Jun 2025.
Related trials for Shortness of Breath
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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 nebulized epinephrine and Salbutamol in people with Shortness of Breath and Asthma in Children, run by Oman Medical Speciality Board at 1 site in Oman.
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 7 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 6 Jun 2025. 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 Oman. 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.
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?
change in pediatric respiratory assessment measure (PRAM) score (time frame: at (60) mints). The study lists 3 primary outcomes in all. 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 6 Jun 2025.