Nebulized Budesonide vs. Placebo in Adults with Asthma Attack; a Double Blind Randomized Placebo-Controlled Clinical Trial
Introduction: Asthma is one of acute respiratory diseases leading to emergency department (ED) referral. Management of acute attack plays an important role in its outcome. Objective: This trial was designed to evaluate the effectiveness of nebulized budesonide versus placebo in moderate to severe acute asthma attack in adults in the ED. Method: In this clinical trial, we enrolled patients with acute exacerbation of asthma and standard treatment of acute asthma attack was administered to all of them. 41 patients in our study were randomly entered into 2 groups. In one group, we prescribed nebulized budesonide and in the other group nebulized placebo (normal saline) was administered. Patients’ demographic data, vital signs, symptoms’ acuity and the time of symptom relief, patient and physician satisfaction were all recorded and compared between the 2 groups. All cases were followed and disease outcome, readmission, mortality and morbidity rates were documented. Results: In this study, 20 patients were entered the budesonide group and 19 patients were enrolled in the placebo group. The mean age ranges were 55.70±15.30 and 60.32±18.41 years old respectively. Heart rate, respiratory rate and O2 saturation in the first group were improved significantly after the treatment in comparison to the second group (p<0.05). The mean time of recovery and length of hospital stay were better in the first group than the second group but this difference was not significant (p>0.05). Conclusion: The addition of nebulized budesonide to standard asthma treatment might result in more improvement in O2 saturation and less patient’s distress.
2. Lee M-Y, Tsai Y-G, Chen C-J, Kuen-Der Yang D, Chu D-M, Cheng S-N, et al. Comparative Efficacy of Nebulized Budesonide to Intravenous Betamethasone Treatment for Acute Childhood Asthma. J Med Sci. 2004;24(2):85-9.
3. Castro-Rodriguez JA, Rodrigo GJ. Efficacy of inhaled corticosteroids in infants and preschoolers with recurrent wheezing and asthma: a systematic review with meta-analysis. Pediatrics. 2009;123(3):e519-25.
4. Adkinson Jr NF, Bochner BS, Burks AW, Busse WW, Holgate ST, Lemanske RF, et al. Middleton's Allergy E-Book: Principles and Practice: Elsevier Health Sciences; 2013.
5. Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008;31(1):143-78.
6. Su XM, Yu N, Kong LF, Kang J. Effectiveness of inhaled corticosteroids in the treatment of acute asthma in children in the emergency department: a meta-analysis. Ann Med. 2014;46(1):24-30.
7. Edmonds ML, Camargo CA, Jr., Pollack CV, Jr., Rowe BH. The effectiveness of inhaled corticosteroids in the emergency department treatment of acute asthma: a meta-analysis. Ann Emerg Med. 2002;40(2):145-54.
8. Tan WC, Lamm CJ, Chen YZ, O'Byrne PM, Pedersen S, Busse WW, et al. Effectiveness of early budesonide intervention in Caucasian versus Asian patients with asthma: 3-year results of the START study. Respirology. 2006;11(6):767-75.
9. Busse WW, Pedersen S, Pauwels RA, Tan WC, Chen YZ, Lamm CJ, et al. The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: effectiveness of early intervention with budesonide in mild persistent asthma. J Allergy Clin Immunol. 2008;121(5):1167-74.
10. Razi E, Nasiri O, Akbari H, Razi A. Correlation of arterial blood gas measurements with venous blood gas values in mechanically ventilated patients. Tanaffos. 2012;11(4):30-5.
11. Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998;5(3):209-13.
12. Devidayal, Singhi S, Kumar L, Jayshree M. Efficacy of nebulized budesonide compared to oral prednisolone in acute bronchial asthma. Acta Paediatr. 1999;88(8):835-40.
13. McLaughlin T, Leibman C, Patel P, Camargo CA, Jr. Risk of recurrent emergency department visits or hospitalizations in children with asthma receiving nebulized budesonide inhalation suspension compared with other asthma medications. Curr Med Res Opin. 2007;23(6):1319-28.