Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Asthma in Children
Effectiveness of Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Acute Asthma in Children in Suez Canal University Hospital Emergency Department: A Randomized Control Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Asthma is a problem that affects many children and affects their physical health in addition to having a social and financial burden on individuals, families and healthcare systems. In our pediatric emergency department, nebulizers are still used for the management of asthma and, with the poor resources of families, they have no option of treatment at home. In this study, the investigators will compare the effectiveness of treatment through nebulizer versus metered dose inhaler and spacer in children with an acute asthmatic attack seeking medical care at the Pediatric Emergency Department of Suez Canal University Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedApril 4, 2019
April 1, 2019
10 months
January 22, 2019
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical improvement
Clinical respiratory score change (see Study Protocol for details)
1 hour
Secondary Outcomes (2)
Rate of Hospitalization
4 hours
Patient satisfaction
1 hour
Study Arms (2)
Nebulizer
ACTIVE COMPARATORContaining salbutamol
Metered Dose Inhaler and spacer
EXPERIMENTALContaining Salbutamol
Interventions
Delivery of appropriate dose according to weight
Medication will be delivered through inhaler and spacer
Eligibility Criteria
You may qualify if:
- Children ranging from 2 - 14 years old.
- Both genders will be included.
- Patients with an acute exacerbation of asthma.
You may not qualify if:
- Patients with arrhythmia and cardiac diseases.
- Patients with thyroid diseases.
- Patients with bronchiolitis, pneumonia. Patients with status asthmaticus requiring immediate pediatric intensive care unit hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suez Canal University Hospital
Ismailia, 11411, Egypt
Related Publications (1)
Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol. 2000 Apr;29(4):264-9. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-s.
PMID: 10738013BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alaa Zeitoun, Prof
Suez Canal University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Pediatrics
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 25, 2019
Study Start
May 15, 2018
Primary Completion
March 15, 2019
Study Completion
March 31, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share