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Comparing the effectiveness, safety, cost and acceptability of salbutamol aerosol inhaler and salbutamol tablet in the treatment of asthma in childre

Phase 4
Recruiting
Conditions
Asthma
Registration Number
SLCTR/2014/012
Lead Sponsor
Base Hospital Embilipitiya
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

1. Clinical diagnosis of acute exacerbation of asthma (see below for case definition)

2. Ages between 6-12 years

3. Receiving in-ward treatment

4. Children who require regular salbutamol in the treatment of acute exacerbation of asthma. This includes

a. Children with severe / moderate acute asthma exacerbation who would be put on regular salbutamol after initial treatment with nebulized salbutamol and other medications

b. Children with mild/moderate asthma who would be straightaway put on regular salbutamol

5.Not used any form of inhaled medications previously

6.Not on nebulized salbutamol at the time of enrollment

7.Not on any other bronchodilators at the time of enrollment

Case definition of Clinically diagnosed to have Bronchial asthma acute exacerbation
1.Previously diagnosed with bronchial asthma (at least one episode with written evidence)
2.Presenting with progressively increasing episodes of shortness of breath, cough, wheeze or chest tightness or combination of these symptoms
3.Presence of bilateral rhonchi on auscultation of lungs

Exclusion Criteria

1.Children having long term co-morbidities

2.Children on long term co-medications

3.Children/ parents who cannot be trained to use inhalers for one reason or other

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of children successfully treated children within 3 days. Successful treatment: will be objectively determined using Pulmonary Score” (a validated score) [The blinded outcome assessor (BOA) will be assessing each participant: <br>twice a day when the child is on the intervention and whenever required (maximum duration 3 days)<br>]<br>
Secondary Outcome Measures
NameTimeMethod
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