Title : Tacrolimus Nebulization as an adjunctive medication for severe acute Asthma; A randomized controlled trial
Background: As a chronic disease of respiratory system, asthma affects millions of people. Because of its suboptimal control, it remains as a burden for health systems. Immune-suppressive agents are the most prescribed medications in asthma patients. Tacrolimus is an immune suppressor medication that is believed to be helpful in asthma control. The aim of the current research is to evaluate the effects of Tacrolimus on improving clinical symptoms, FEV1 and PEFR in patients with acute asthma attack.
Methods: The study was carried out on 82 initial enrolled patients with severe asthma, in a block randomization of whom were referred to emergency departments due to acute asthma attack. The control group received 0.5 mg ipratropium bromide nebulize along with 5 mg albuterol nebulize, repeated three doses with interval of 20 minutes, and also a single dose of 50 mg oral Prednisolone at the beginning of trial. The intervention group received the same treatment as the above control group plus single dose of 2 mg nebulized Tacrolimus at the beginning of trial. Pulmonary function (FEV1 and PEFR), clinical symptoms (Borg Dyspnea Scale), hemodynamic variables (blood pressure, pulse and respiration rate, O2 saturation) were compared at minutes 0, 30, 60, 90 and 120 after the intervention for all the studied patients.
Results: There were 55.7% female and 44.3% male with a mean age and the mean onset of asthma 38.24 ± 9.7(Range: 18 -55) and 4.3 ± 1.86(Range: 1-8) years, respectively. The FEV1 and PEFR levels before intervention and at various time points after intervention did not show any statistically significant differences. Also, dyspnea severity in different time points did not show significant differences in both groups.
Conclusion: Our findings indicate that Tacrolimus (FK 506) possibly is not efficacious to be used as an acute phase medication in controlling severe asthma attack.