کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8757554 | 1596409 | 2018 | 21 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The use of methacholine provocation when assessing therapeutic equivalence between two inhalers in asthmatic patients
ترجمه فارسی عنوان
استفاده از تحریک متاکولین هنگام ارزیابی معادله درمانی بین دو رادیاتور در بیماران مبتلا به آسم
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موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
پزشکی و دندانپزشکی (عمومی)
چکیده انگلیسی
A planned change from Bricanyl® (terbutaline) Turbuhaler® M2 to M3 device required a pharmacodynamic study to evaluate therapeutic equivalence of the two devices. Because of the flat dose-response curve for this type of agent over this dose range when assessing bronchodilation, a bronchoprotection study was considered more feasible. In this double-blind, double-dummy, multicentre, single-dose, two-factor, crossover study, patients with stable mild-to-moderate asthma were randomised to 0.5 or 1.5â¯mg terbutaline via Turbuhaler® M2 or Turbuhaler® M3 followed by a methacholine challenge test. Primary outcome variable: concentration of methacholine causing a 20% fall in FEV1 (PC20). Pairwise contrasts were constructed with 95% CIs to determine assay sensitivity for M2 and M3 devices and therapeutic equivalence at each dose level (95% CI for M3:M2 devices within pre-specified limit [0.67-1.50]) and the relative dose-potency (RDP) between M3 and M2 determined with 90% CI. Sixty patients were randomised and all completed the study. Between-device ratios of PC20 (M3:M2) were 0.92 (95% CI: 0.75-1.13) for 0.5â¯mg and 0.88 (95% CI 0.72-1.08) for 1.5â¯mg and estimated RDP was 1.20 (0.96-1.53). In conclusion, a methacholine provocation study (PC20 primary variable) is a useful alternative to the standard bronchodilation study when assessing therapeutic equivalence of a bronchodilator.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 67, April 2018, Pages 87-90
Journal: Contemporary Clinical Trials - Volume 67, April 2018, Pages 87-90
نویسندگان
Thomas Bengtsson, Jonas Román, Tore Persson,