A MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-PERIOD CROSSOVER STUDY WITH GSK 573719 AS MONOTHERAPY IN ADULT SUBJECTS WITH ASTHMA

GlaxoSmithKline,0 个研究点目标入组 87 人开始时间: 2012年8月24日最近更新: 2023年9月4日

试验速览

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•1. INFORMED CONSENT: SUBJECTS MUST GIVE THEIR SIGNED AND DATED WRITTEN INFORMED CONSENT TO PARTICIPATE.
•2. TYPE OF SUBJECT: OUT-PATIENTS. HOWEVER A SUB-GROUP OF SUBJECTS FROM SELECTED SITES WILL REMAIN IN THE CLINIC OVERNIGHT AT THE END OF EACH TREATMENT PERIOD FOR SERIAL SAFETY, EFFICACY AND PK BLOOD AND URINE ASSESSMENTS OVER A 24 HOUR PERIOD.
•3. AGE: 18 YEARS OF AGE OR OLDER AT VISIT 1.
•4. DIAGNOSIS: DIAGNOSIS OF ASTHMA AS DEFINED BY THE NATIONAL INSTITUTES OF HEALTH [NIH, 2007] AT LEAST 6 MONTHS PRIOR TO VISIT 1.
•5. GENDER: MALE OR ELIGIBLE FEMALE, ELIGIBLE BEING DEFINED AS OF NON-CHILDBEARING POTENTIAL OR CHILDBEARING POTENTIAL USING AN ACCEPTABLE METHOD OF BIRTH CONTROL CONSISTENTLY AND CORRECTLY, AS DEFINED BY THE FOLLOWING:
•MALE PARTNER WHO IS STERILE PRIOR TO THE FEMALE SUBJECT´S ENTRY INTO THE STUDY AND IS THE SOLE SEXUAL PARTNER FOR THAT FEMALE SUBJECT
•IMPLANTS OF LEVONORGESTREL OR ETONOGESTREL
•INJECTABLE PROGESTOGEN
•ORAL CONTRACEPTIVE (EITHER COMBINED OR PROGESTOGEN ALONE)
•ESTROGENIC VAGINAL RING
•PERCUTANEOUS CONTRACEPTIVE PATCHES
•ANY INTRAUTERINE DEVICE (IUD) WITH A DOCUMENTED FAILURE RATE OF LESS THAN 1 % PER YEAR.
•MALE CONDOM COMBINED WITH A VAGINAL SPERMICIDE (FOAM, GEL, FILM, CREAM, OR SUPPOSITORY)

•• HISTORY OF LIFE-THREATENING ASTHMA: DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBATION AND/OR WAS ASSOCIATED WITH HYPERCAPNEA, RESPIRATORY ARREST OR HYPOXIC SEIZURES WITHIN THE LAST 5 YEARS.
•ASTHMA EXACERBATION: A SUBJECT MUST NOT HAVE A HISTORY OF ASEVERE ASTHMA EXACERBATION WITHIN 4 WEEKS PRIOR TO VISIT 1. ASEVERE ASTHMA EXACERBATION IS DEFINED AS DETERIORATION OF ASTHMA REQUIRING THE USE OF SYSTEMIC CORTICOSTEROIDS (ORAL, OR INJECTION) FOR AT LEAST 3 DAYS OR AN INPATIENT HOSPITALIZATION OR EMERGENCY DEPARTAMENT VISIT DUE TO ASTHMA THAT REQUIRED SYSTEMIC CORTICOSTEROIDS.
•RESPIRATORY INFECTION EXPECTED TO AFFECT THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY: WITHIN 4 WEEKS PRIOR TO VISIT 1 A SUBJECT HAS HAD A CULTURE DOCUMENTED OR SUSPECTED BACTERIAL OR VIRAL INFECTION OF THE UPPER OR LOWER RESPIRATORY TRACT, SINUS OR MIDDLE EAR THAT IS NOT RESOLVED AND HAS LED TO A CHANGE IN ASTHMA MANAGEMENT OR, IN THE OPINION OF THE INVESTIGATOR, IS EXPECTED TO AFFECT THE SUBJECT´S ASTHMA STATUS OR THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY.

发起方

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