A DOSE-RANGING STUDY OF VILANTEROL (VI) INHALATION POWDER IN CHILDREN AGED 5-11 YEARS WITH ASTHMA ON A BACKGROUND OF INHALED CORTICOSTEROID THERAPY

GlaxoSmithKline,0 个研究点目标入组 71 人开始时间: 2012年5月22日最近更新: 2023年9月4日

试验速览

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•1. INFORMED CONSENT: WRITTEN INFORMED CONSENT FROM AT LEAST ONE PARENT/LEGAL GUARDIAN TO TAKE PART IN THE STUDY.
•IF APPLICABLE, SUBJECT MUST BE ABLE AND WILLING TO GIVE ASSENT TO TAKE PART IN THE STUDY ACCORDING TO THE LOCAL REQUIREMENT. THE STUDY INVESTIGATOR IS ACCOUNTABLE FOR DETERMINING A CHILD´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 MEDICATION AND STUDY ASSESSMENTS INCLUDING RECORDING OF SYMPTOM SCORES AND 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 FEMALE. PRE-MENARCHIAL FEMALES ARE DEFINED AS ANY FEMALE WHO HAS YET TO BEGIN MENSES.
•4. DIAGNOSIS OF ASTHMA: SUBJECTS MUST HAVE A HISTORY OF SYMPTOMS CONSISTENT WITH A DIAGNOSIS OF ASTHMA FOR AT LEAST 6 MONTHS PRIOR TO VISIT 1.

•1. LIFE THREATENING ASTHMA: SUBJECTS WITH A HISTORY OF LIFE-THREATENING ASTHMA. DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBATION, HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT, RESPIRATORY ARREST, HYPOXIC SEIZURES OR ASTHMA-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 THE 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 IS PROHIBITED ACCORDING TO THE TIMEFRAMES BELOW
•4. INFECTIONS: CULTURE-DOCUMENTED OR SUSPECTED BACTERIAL OR VIRAL INFECTION OF THE UPPER OR LOWER RESPIRATORY TRACT, SINUS OR MIDDLE EAR THAT IS NOT RESOLVED WITHIN 4 WEEKS OF VISIT 1 AND LED TO A CHANGE IN ASTHMA MANAGEMENT OR, IN THE OPINION OF INVESIGATOR, IS EXPECTED TO AFFECT THE SUBJECT´S ASTHMA STATUS OR THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY.

发起方

GlaxoSmithKline,