Asthma
Conditions
Interventions
Arm 1: Salbutamol metered dose inhalation aerosol (100 microgram/ puff, delivered via spacer device) at the dose of 200 microgram administered 8 hourly at 8 am, 2 pm and 8 pm for 3 days* (9 doses). Si
Sponsors
Base Hospital Embilipitiya
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: twice a day when the child is on the intervention and whenever required (maximum duration 3 days) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean duration taken for successful treatment in children responded in 3 days or less 2. Number of children requiring nebulized salbutamol and/ or other bronchodilators during the trial period(they will be considered as non-successfully treated) 3. Duration of hospital stay (related to treatment of asthma) 4. Changes in Peak Expiratory Flow Rate 5. Adverse effects of salbutamol 6. Cost of salbutamol treatment 7. Days taken to return to school 8. Recurrence of symptoms of asthma exacerbations within 2 weeks of stopping the treatment 9. Revisits to hospitals/ GP within two weeks of discharge with symptoms of asthma exacerbation 10. Acceptability, convenience and suitability of intervention [Outcomes 1-5: The blinded outcome assessor (BOA) will be assessing each participant twice a day when the child is on the intervention and whenever required (maximum duration 3 days) -using the follow up questionnaire and adverse reaction check list Outcome 6: Will be assessed at the end of the trial Outcome 7: 2-3 days after discharge, by telephone interview Outcomes 8, 9: 2 weeks after discharge by telephone interview Outcome 10: Day of discharge (by self administered questionnaire to mother/carer) ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Shalini Sri Ranganathan (PI)
Professor in Pharmacology and Consultant Paediatrician
Outcome results
None listed