In vivo efficacy of Salbutamol Sandoz versus salbutamol Ventolin GSK in children with asthma - Salsa

Radboud University Medical Center0 个研究点目标入组 80 人开始时间: 2018年6月4日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•- Informed consent of the parents of children up to 12 yrs of age, and informed consent from parents/caretakers of children and of the children aged 12-14 years. van ouders bij kinderen tot 12 jaar, en informed consent van ouders en assent van kinderen bij de leeftijd van 12-14 jaar
•- Children known with doctor’s diagnosed asthma, and a history, or physical examanation, or documented positive response on bronchodilators following lung function testing, indicating reversibility of airways obstruction
•- C-ACT (children astma controle test questionnaire 4-11 yrs) or ACT(12-16 yrs) <20 and/or FEV1 decline of at least 15% compared to personal's best and/or FEV1 < 80 % of predicted value and/or such symptoms that the parents or the physician would administer a bronchodilator
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•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 0

•- Severe acute asthma for which high and frequent dosages of Salbutamol are needed
•- Inability to conduct a lung function test well
•- Inability to read or understand the Dutch Language
•- Concomitant other chronic physical or mental condition that precludes conducting a reliable lung function test.

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