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Randomized Controlled Trial
. 2012 Mar 7:12:21.
doi: 10.1186/1471-2431-12-21.

Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

Jenish J Arun  1 , Rakesh Lodha, Sushil K Kabra
Affiliations
Randomized Controlled Trial

Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

Jenish J Arun et al. BMC Pediatr. .

Abstract

Background: There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively) combination with budesonide (200 μg)/salbutamol (200 μg) administered by metered dose inhaler and spacer in children of 5-15 years with mild acute exacerbation of asthma [Modified Pulmonary Index Score (MPIS) between 6-8] in this double-blind, randomized controlled trial. The primary outcome was FEV1 (% predicted) in the two groups at 1, 5, 15, 30, 60 min after administration of the study drug.

Results: We did not observe any significant differences in the % predicted FEV1 and MPIS between formoterol and salbutamol at various time points from 1 min to 60 min post drug administration. There was significant improvement in FEV1 (% predicted) from baseline in both the groups as early as 1 min after drug administration.

Conclusions: Salbutamol or formoterol delivered along with inhaled corticosteroid by metered dose inhaler with spacer in children between 5-15 years of age with mild acute exacerbation of asthma had similar bronchodilatory effects.

Trial registration: ClinicalTrials.gov: NCT00900874.

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Figures

Figure 1
Figure 1
Trial profile. ITT: Intention to treat.
Figure 2
Figure 2
% predicted FEV1 at different time points in the 2 groups.
See this image and copyright information in PMC

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