Study of efficacy and safety of levosalbutamol versus racemic salbutamol delivered by metered dose inhaler in children with moderate persistent asthma

Sarita Sharma, Joseph L. Mathew, Meenu Singh

Abstract


Aim: To compare the efficacy and safety of Levosalbutamol versus racemic Salbutamol delivered by metered dose inhaler in children with moderate persistent asthma. Materials and Methods: Children enrolled in the study were randomized to receive MDI Levosalbutamol 2 puff thrice daily, 50 µgm/puff (group A) or MDI Racemic Salbutamol 2 puff thrice daily. 100 µgm/puff (group B).Baseline characteristics of both groups were comparable. The FEV1 % and PEF % were assessed at baseline, at 15 minutes following the first dose on day 1 and on day 8. In children who remained symptomatic on day 8, an additional evaluation on day 15 was performed. Asthma symptom score were calculated from symptom score card. Results: There was significant improvement in PEF % and FEV1 % within each group. But there was no statistically significant inter-group difference in PEF % change and FEV1 % change except mean change in PEF % and ∆PEF % of initial on day 8 (at the end of 1 week). Asthma symptom score improved significantly in both groups but there was no inter group difference. Incidence of side effects like decrease in serum potassium level and increase in heart rate were comparable in between the two groups. Conclusion: Levosalbutamol administered via MDI improved PEF % significantly more in comparison of racemic Salbutamol after regular use of one week. However, no significant differences were observed in between the two drugs with respect to pulmonary function test on day 1, FEV1 % on day 8 and asthma symptom score. The side effect profile of the two drugs was comparable. This suggests that Levosalbutamol is at least as efficacious as conventional Salbutamol in terms of clinical efficacy.

Full Text:

PDF HTML

References


Chaudry I, Banerjee P, inventors; Dey Laboratories Inc, assignee. Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma. United States patent US 6,702,997. 2004 Mar 9.

Boulton DW, Fawcett JP. The pharmacokinetics of levosalbutamol: what are the clinical implications? Clin Pharmacokinet. 2001 Jan;40(1):23-40.DOI:10.2165/000 03088-200140010-00003

Maier G, Rubino C, Hsu R, Grasela T, Baumgartner RA. Population pharmacokinetics of (R)-albuterol and (S)-albuterol in pediatric patients aged 4–11 years with asthma. Pulmonary pharmacology & therapeutics. 2007 Oct 1; 20(5):534-42.

Punj A, Prakash A, Bhasin A. Levosalbutamol vs racemic salbutamol in the treatment of acute exacerbation of asthma. Indian J Pediatr. 2009 Nov;76 (11): 1131-5. doi: 10.1007/s12098-009-0245-4.

Gupta MK, Singh M. Evidence based review on levosalbutamol. Indian J Pediatr. 2007 Feb;74(2):161-7.

Batra V, Niazi S, Peters SP. Persistent asthma: what approach is best? The focus of therapy is on inflammation. Journal of Respiratory Diseases. 2002 Jun 1;23 (6): 330-40.

Huang YJ, Nelson CE, Brodie EL, et al. Airway microbiota and bronchial hyper responsiveness in patients with suboptimally controlled asthma. J Allergy Clin Immunol. 2011 Feb;127(2):372-381.e1-3. doi: 10. 1016/j. jaci. 2010.10.048. Epub 2010 Dec 30.

Lötvall J, Palmqvist M, Arvidsson P, et al. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31.DOI:10.1067/mai. 2001. 119152

Handley DA, McCullough JR, Crowther SD, et al. Sympathomimetic enantiomers and asthma. Chirality. 1998;10(3):262-72.DOI:10.1002/(SICI)1520-636X (1998) 10:3<262:: AID-CHIR9>3.0.CO;2-B

Nowak RM, Pensler MI, Sarkar DD, Anderson JA, et al. Comparison of peak expiratory flow and FEV1 admission criteria for acute bronchial asthma. Ann Emerg Med. 1982 Feb;11(2):64-9.

Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001 Aug;108(2): E36.DOI: 10. 1542/peds.108.2.e36

Maiti R, Prasad CN, Jaida J, et al. Racemic salbutamol and levosalbutamol in mild persistent asthma: A comparative study of efficacy and safety. Indian J Pharmacol. 2011 Nov;43(6):638-43. doi: 10. 4103/ 0253-7613.89817.

Gawchik SM, Saccar CL, Noonan M, et al. The safety and efficacy of nebulized levalbuterol compared with racemic albuterol and placebo in the treatment of asthma in pediatric patients. J Allergy Clin Immunol. 1999 Apr;103(4):615-21.

Jantikar A, Brashier B, Maganji M, et al. Comparison of bronchodilator responses of levosal-butamol and salbutamol given via a pressurized metered dose inhaler: a randomized, double blind, single-dose, crossover study. Respir Med. 2007 Apr; 101(4): 845-9. Epub 2007 Feb 1.

Ameredes BT, Calhoun WJ. Modulation of GM-CSF release by enantiomers of beta-agonists in human airway smooth muscle. J Allergy Clin Immunol. 2005 Jul;116(1):65-72. DOI:10.1016/j.jaci.2005.03.007


Refbacks

  • There are currently no refbacks.