Non sedating antihistamines urticaria treatment
While these studies indicate that the treatment schedule can generally have a major impact on the outcome of treatment, the results on the efficacy of on-demand ns AHs in CSU have not yet been independently confirmed.In addition, it has not been studied whether on-demand ns AHs in higher than standard doses might have a beneficial effect compared with standard doses.
Please review the following URL and make sure that it is spelled correctly: Try starting over at The Royal Children's Hospital home page or search our site.Most clinical trials rely on patient assessments of symptoms and quality of life over a period of outpatient treatment time.Although this is entirely appropriate, we designed the current clinical study to examine the efficacy of standard dose desloratadine (5 mg) and up-dosed desloratadine (20 mg) on existing wheals, under carefully monitored conditions, using the most technically reliable, objective measures.In addition, patients were excluded if they met any criteria from a typical list of exclusion criteria for pharmacological studies: presence of a permanent gastrointestinal condition that may influence oral therapy, history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischaemia, history or presence of myocardial infarction or cardiac arrhythmia that requires drug therapy, evidence of severe renal dysfunction, evidence of significant hepatic disease, presence of active cancer that requires chemotherapy, presence of alcohol abuse or drug addiction, participation in any clinical trial within 4 weeks prior to enrolment, pregnancy or breast-feeding, and existing or planned placement in an institution after ruling according to § 40 AMG (Arzneimittelgesetz). This was considered sufficient to adequately investigate the objectives of this study, based upon the investigator’s experience and previous studies on urticaria.
Formally, our study had a power of 80% to detect effects of size 1.085 (quotient difference of means and standard deviation). At visit 1, screening for eligibility was performed, and patients were requested to stop taking any antihistamines for the duration of the study, if possible.
METHODS Ethics This study (identifier NCT00598611, Eudra CT-No: 2006-001431-22) was approved by the Independent Ethics Committee of Berlin (Ethikkommission des Landes Berlin) and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, Bf Ar M).