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CompletedNCT06754631Updated Jan 1, 2025

Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age

An interventional study of Continuous Nebulization of Salbutamol and Intermittent Nebulization of Salbutamol in Asthma in Children, sponsored by Muhammad Aamir Latif. Completed at 2 sites in Pakistan. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-01-01.

Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asthma in Children
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 120 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

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

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

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

Study arms

  • Experimental
    Continuous Nebulization of Salbutamol

    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).

    Drug: Continuous Nebulization of Salbutamol

  • Experimental
    Intermittent Nebulization of Salbutamol

    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.

    Drug: Intermittent Nebulization of Salbutamol

Interventions

  • DrugContinuous Nebulization of Salbutamol

    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).

  • DrugIntermittent Nebulization of Salbutamol

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 hours

Secondary outcomes

  1. Hospital stay

    The length of stay in the hospital was calculated from admission to discharge.

    Time frame: 24 hours

07

Study locations

2 sites
  • Nishtar Hospital
    Multan, Punjab 66000, Pakistan
  • The Children's Hospital and The Institute of Child Health
    Multan, Punjab 66000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06754631
Lead sponsor
Muhammad Aamir Latif
Collaborators
Nishtar Medical University
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
Jan 1, 2025
Start date
Apr 1, 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024
Last update
Jan 1, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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