Asthma in ChildrenNCT06754631
Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age
A study testing Continuous Nebulization of Salbutamol and Intermittent Nebulization of Salbutamol in people with Asthma in Children, run by Muhammad Aamir Latif at 2 sites in Pakistan.
Trial summary
Asthma affects around 260 million people globally, causing around 0.5 million deaths annually. Pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Continuous Nebulization of Salbutamol and Intermittent Nebulization of Salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Apr 2024to 30 Sep 2024
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either gender
- Aged 2 to 12 years
- Diagnosed with moderate exacerbation of acute asthma according to British Guidelines on the Management of Asthma, with a clinical asthma score of 8 or more
Who cannot join
- Children who were prescribed with other first-line therapy, such as adrenaline or 3% NaCl nebulization
- Presented at imminent risk of respiratory arrest
- Congenital heart disease
- Chronic respiratory disease
- Neurological disorders
- Children referred from any other hospital with no data available on emergency treatment
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Nishtar Hospital
Multan, Punjab Province, 66000
The Children's Hospital and The Institute of Child Health
Multan, Punjab Province, 66000
About this study
Asthma affects around 260 million people globally, causing around 0.5 million deaths annually. Pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. Therefore, this study was planned to compare the effects of continuous versus intermittent nebulization of salbutamol in the treatment of acute severe asthma (ASA) in children visiting the emergency department of a tertiary childcare hospital in South Punjab, Pakistan.
- Conditions
- Asthma in Children
- Being tested
- Continuous Nebulization of Salbutamol, Intermittent Nebulization of Salbutamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Nebulization of SalbutamolDrug
Children received continuous nebulization of salbutamol at a concentration of 0.3 mg/kg/hour for 4 hours, with a minimum of 5 mg/hour and a maximum of 15 mg/hour administered via High Output Extended Aerosol Respiratory Therapy (HEART).
Intermittent Nebulization of SalbutamolDrug
were treated with intermittent nebulization of salbutamol at a dose of 0.15 mg/kg/dose, administered through a face mask with an oxygen flow rate of 6-8 L per minute. They Children received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Nebulization of Salbutamol | Experimental | The patients received continuous nebulization of salbutamol at a concentration of 0.3 mg/kg/hour for 4 hours, with a minimum of 5 mg/hour and a maximum of 15 mg/hour administered via high-output extended aerosol respiratory therapy (HEART). Receives: Drug: Continuous Nebulization of Salbutamol |
| Intermittent Nebulization of Salbutamol | Experimental | The patients were treated with intermittent nebulization of salbutamol at a dose of 0.15 mg/kg/dose, administered through a face mask with an oxygen flow rate of 6-8 L per minute. They received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours. Receives: Drug: Intermittent Nebulization of Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge
When patients met the clinical criteria for discharge, which were an asthma score of 5 or less and a saturation level of over 94% on room air.
Measured: 4 hours
Secondary outcomes (1)
Hospital stay
The length of stay in the hospital was calculated from admission to discharge.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Apr 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Collaborators
- Nishtar Medical University
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Arif Zulqarnain, FCPS, Study director, Children's Hospital and institute of Child Health Multan, Punjab, PakistanMuhammad Salman, FCPS, Principal investigator, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754631
- Sponsor's protocol ID
- CHM-1
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zulqarnain A, Fayyaz A, Zafar S, Fatima B. Continuous versus intermittent nebulization of salbutamol in acute Severe asthma in children under 12 years of age. Pak J Med Sci. 2026 Jan;42(1):185-190. doi: 10.12669/pjms.42.1.11935.
PubMed 41737184
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age
- ClinicalTrials.gov ID
- NCT06754631
- Acronym / sponsor ID
- CHM-1
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Collaborators
- Nishtar Medical University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Jan 2025 (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.
Asthma affects around 260 million people globally, causing around 0.5 million deaths annually. Pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. Therefore, this study was planned to compare the effects of continuous versus intermittent nebulization of salbutamol in the treatment of acute severe asthma (ASA) in children visiting the emergency department of a tertiary childcare hospital in South Punjab, Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Nebulization of Salbutamol | Experimental | Drug: Continuous Nebulization of SalbutamolThe patients received continuous nebulization of salbutamol at a concentration of 0.3 mg/kg/hour for 4 hours, with a minimum of 5 mg/hour and a maximum of 15 mg/hour administered via high-output extended aerosol respiratory therapy (HEART). |
| Intermittent Nebulization of Salbutamol | Experimental | Drug: Intermittent Nebulization of SalbutamolThe patients were treated with intermittent nebulization of salbutamol at a dose of 0.15 mg/kg/dose, administered through a face mask with an oxygen flow rate of 6-8 L per minute. They received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of either gender
- Aged 2 to 12 years
- Diagnosed with moderate exacerbation of acute asthma according to British Guidelines on the Management of Asthma, with a clinical asthma score of 8 or more
Key exclusion criteria (6 listed)
- Children who were prescribed with other first-line therapy, such as adrenaline or 3% NaCl nebulization
- Presented at imminent risk of respiratory arrest
- Congenital heart disease
- Chronic respiratory disease
- Neurological disorders
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 |
|---|---|---|
| Continuous Nebulization of SalbutamolChildren received continuous nebulization of salbutamol at a concentration of 0.3 mg/kg/hour for 4 hours, with a minimum of 5 mg/hour and a maximum of 15 mg/hour administered via High Output Extended Aerosol Respiratory Therapy (HEART). | Drug | Continuous Nebulization of Salbutamol |
| Intermittent Nebulization of Salbutamolwere treated with intermittent nebulization of salbutamol at a dose of 0.15 mg/kg/dose, administered through a face mask with an oxygen flow rate of 6-8 L per minute. They Children received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours. | Drug | Intermittent Nebulization of Salbutamol |
Primary outcome
Discharge
Time frame: 4 hours
When patients met the clinical criteria for discharge, which were an asthma score of 5 or less and a saturation level of over 94% on room air.
1 secondary outcome
Hospital stay
Time frame: 24 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 1 Jan 2025.
- Derived from this study: PubMed 41737184Zulqarnain A, Fayyaz A, Zafar S, Fatima B. Continuous versus intermittent nebulization of salbutamol in acute Severe asthma in children under 12 years of age. Pak J Med Sci. 2026 Jan;42(1):185-190. doi: 10.12669/pjms.42.1.11935.
- Individual participant dataSharing planned: No
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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.
Arif Zulqarnain, FCPS study director
Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
Muhammad Salman, FCPS principal investigator
Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Nebulization of Salbutamol and Intermittent Nebulization of Salbutamol in people with Asthma in Children, run by Muhammad Aamir Latif at 2 sites in Pakistan.
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 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Discharge (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754631, which also lists 1 linked publication.
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 Jan 2025.