Rapid Onset Action of Salbutamol Versus Formoterol

Study Overview
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Brief Summary
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The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.

Detailed Description
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It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma. Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.

Official Title
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Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: salbutamol
* Drug: Formoterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD Mild exacerbation will be defined as: children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration no chest indrawing no difficulty in speech clinical asthma score (or pulmonary index score-annexure 1) between 6-9 Exclusion Criteria: Children with life threatening asthma detected by presence of any of the following: severe chest indrawing cyanosis irregular respiration altered sensorium Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol) Child not able to perform spirometry Parents refusing to give consent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Salbutamol + steroid | Drug: salbutamol<br>* two puffs (100 microgram each of salbutamol) by MDI and spacer<br>|
| Active Comparator: 2<br>Formoterol + steroid | Drug: Formoterol<br>* Formoterol 2 puffs (6 µg /puff) by MDI and spacer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in average clinical asthma score between two groups |  | 60 min | 
| Adverse effects like tremors, vomiting, palpitation, etc, in two groups |  | 60 mins | 
| Number of patients requiring hospitalization in two groups at end of study period in two groups |  | 60 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Formoterol, Rapid bronchodilation