PER-124-11未知未知
A DOSE-RANGING STUDY OF FLUTICASONE FUROATE (FF) INHALATION POWDER IN CHILDREN AGED 5-11 YEARS WITH ASTHMA
GlaxoSmithKline,0 个研究点目标入组 96 人开始时间: 2012年3月27日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5 至 11（—）
- 性别
- All
入选标准
- •1. INFORMED CONSENT: WRITTEN INFORMED CONSENT FROM AT LEAST ONE PARENT/CARE GIVER AND ACCOMPANYING INFORMED ASSENT FROM THE SUBJECT (WHERE THE SUBJECT IS ABLE TO PROVIDE ASSENT) PRIOR TO ADMISSION TO THE STUDY.
- •IF APPLICABLE, SUJECT MUST BE ABLE AND WILLING TO GIVE ASSENT TO TAKE PART IN THE STUDY ACCORDING TO THE LOCAL REQUERIMENT. THE STUDY INVESTIGATOR IS ACCOUNTABLE FOR DETERMINING A HILD´S CAPACITY TO ASSENT TO PARTICIPATION IN A RESEARCH STUDY, TAKING INTO CONSIDERATION ANY STANDARDS SET BY THE RESPONSIBLE IEC/IRB.
- •SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THE STUDY REQUIRES THEM TO BE TREATED ON AN OUTPATIENT BASIS.
- •SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THEY MUST COMPLY WITH STUDY ASSESSMENT INCLUDING RECORDING OF SYMPTOM SCORE AN RESCUE ALBUTEROL/SALBUTAMOL USE, ATTENDING SCHEDULED STUDY VISITS, AND BEING ACCESSIBLE BY A TELEPHONE CALL.
- •2. AGE: 5-11 YEARS AT VISIT 1.
- •3. GENDER: MALE AND PRE-MENARCHIAL FEMALES ARE DEFINED AS ANY FEMALE WHO HAS YET TO BEGIN MENSES.
排除标准
- •1. LIFE THREATENING ASTHMA: SUBJECTS WITH A HISTORY OF LIFE-THREATENING ASTHMA, DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INCUBATION, HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT, RESPIRATORY ARREST, HYPOXIC SEIZURES OR ATHSMA-RELATED SYNCOPAL EPISODE(S).
- •2. ASTHMA EXACERBATION: SUBJECTS WITH A HISTORY OF ASTHMA EXACERBATION REQUIRING THE USE OF SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION, OR INJECTION) FOR AT LEAST 3 DAYS OR A DEPOT CORTICOSTEROID INJECTION OR REQUIRING HOSPITALIZATION FOR ASTHMA (WITHIN 6 MONTHS) PRIOR TO SCREENING.
- •3. CONCOMITANT MEDICATIONS: SUBJECTS CURRENTLY RECEIVING (OR HAVE RECEIVED WITHIN 4 WEEKS OF SCREENING) ASTHMA THERAPIES INCLUDING THEOPHYLLINES, LONG-ACTING INHALED BETA-AGONISTS, OR WHO HAVE CHANGED THEIR ASTHMA MEDICATION WITHIN 4 WEEKS OF SCREENING. CONCOMITANT MEDICATION: USE OF THE FOLLOWING MEDICATIONS IN PROHIBITED ACCORDING TO THE TIMEFRAMES BELOW.
研究者
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