Efficacy and Safety of Inhalex® Forte Versus Original Product in Asthmatic Adults: A Comparative Study

Objectives: To compare the efficacy of Inhalex® Forte and Berodual® Forte in stable bronchial asthmatic patients, after a methacholine–induced bronchoconstriction in terms of forced expiratory volume in one second (FEV1) reversal within 90 minutes and adverse reactions. Study design: randomized double-blind cross-over study Methods: The study was conducted at the Asthma Clinic, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen. Inclusion criteria were participants aged from 18 to 60 years old who had stable asthmatic symptoms, FEV1 more than 70% of the predicted normal value and had a positive methacholine provocation test. Exclusion criteria were patients with respiratory tract infection within six weeks, or asthma exacerbations within four weeks or had underlying diseases. Fifty participants completed the study and received a methacholine test and were randomly assigned to receive either one nebule of Inhalex® Forte or Berodual® Forte via micronebulizer. FEV1 was measured at intervals until 90 minutes and reported as area under the curves (AUC) of FEV1. One week apart within two hours of the previous time the participants were allocated to another medication. Participants, research assistants, assessors and data analyzers were blinded to the drug allocation. Oxygen saturation, blood pressure, pulse rate and any occurring adverse effects were monitored. Results: There were 44 female (88%) and six male (12%) participants. Twenty-four patients had a history of allergic rhinitis. Average baseline FEV1 was 2.5 ± 0.5 L. Percentage of FEV1 of predicted normal value was 86.3 ± 10. Median difference of the area under the curve between the two study drugs was 0.36 which was not significantly different (P = 0.86, 95% CI -3.83, 4.94). No patients experienced any tachycardia or hypertension during the tests and no adverse effects occurred during the study. Conclusion: The efficacy of Inhalex® Forte is comparable to Berodual® Forte, and no adverse events occurred in the administration of this drug. รับไว้ตีพิมพ์ เมือวันที่ 19 พฤษภาคม 2558 นิพนธ์ต้นฉบับ