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Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Asthma in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03816267
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mona Azzam, Suez Canal University

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.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Device: Nebulizer Drug: Salbutamol Device: Metered dose inhaler and spacer Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Nebulizer
Containing salbutamol
Device: Nebulizer
Nebulization via mask

Drug: Salbutamol
Delivery of appropriate dose according to weight
Other Name: Albuterol, Ventolin

Experimental: Metered Dose Inhaler and spacer
Containing Salbutamol
Drug: Salbutamol
Delivery of appropriate dose according to weight
Other Name: Albuterol, Ventolin

Device: Metered dose inhaler and spacer
Medication will be delivered through inhaler and spacer
Other Name: MDI




Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 1 hour ]
    Clinical respiratory score change (see Study Protocol for details)


Secondary Outcome Measures :
  1. Rate of Hospitalization [ Time Frame: 4 hours ]
    Admission into inpatient or intensive care unit

  2. Patient satisfaction [ Time Frame: 1 hour ]
    Patient or parent satisfaction using Likert scale (see Study Protocol for details)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ranging from 2 - 14 years old.
  • Both genders will be included.
  • Patients with an acute exacerbation of asthma.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816267


Locations
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Egypt
Suez Canal University Hospital
Ismailia, Egypt, 11411
Sponsors and Collaborators
Suez Canal University
Investigators
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Study Chair: Alaa Zeitoun, Prof Suez Canal University
  Study Documents (Full-Text)

Documents provided by Mona Azzam, Suez Canal University:

Publications:
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Responsible Party: Mona Azzam, Lecturer of Pediatrics, Suez Canal University
ClinicalTrials.gov Identifier: NCT03816267     History of Changes
Other Study ID Numbers: 3244
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Albuterol
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action