Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.

Karen Schow Jensen0 个研究点目标入组 32 人开始时间: 2012年7月31日最近更新: 2020年6月22日

适应症

试验速览

暂无简介。

•Written informed consent from child and parent or guardian.
•Age 10 - 14 years.
•Proven exercise-induced asthma with a decrease in FEV1 of >12%.
•Background medicine: inhaled corticosteroid therapy (equivalent to max 400-800mikg budesonide daily or equipotent doses).
•FEV1 baseline = 85% of predicted normal value.
•Participants must be able to swallow a medicine capsule.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 32
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Inability to use the study equipment correctly.
•Treatment with long acting beta2-agonists.
•Changing the background medication during the study period.
•Short-acting beta2-agonists must not be used within 8 hours before the running test.
•Antihistamines must not be used within 72 hours before the running test.
•Hereditary galactose intolerance.
•If the child is receiving regular montelukast, this treatment must be stopped within two weeks before the commencement of the trial.
•Temperature above 38.5 or infection-related respiratory symptoms on days with scheduled running test.

发起方

Karen Schow Jensen