A RANDOMIZED, DOUBLED-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FLUTICASONE FUROATE INHALATION POWDER AND FLUTICASONE PROPIONATE INHAATION POWDER IN THE TREATMENT OF ASTHMA IN ADULTS AND ADOLESCENTS NOT CURRENTLY TREATED WITH INHALED CORTICOSTEROIDS

GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 119 人开始时间: 2011年11月23日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. INFORMED CONSENT: SUBJECTS MUST GIVE THEIR SIGNED AND DATED WRITTEN INFORMED CONSENT TO PARTICIPATE.
•2. TYPE OF SUBJECT: OUTPATIENTS 12 YEARS OF AGE OR OLDER AT THE VISIT 1 (OR ≥ 18 YEARS OF AGE IF LOCAL REGULATIONS OR TE REGULATORY STATUS OF STUDY MEDICATION PERMIT ENROLMENT OF ADULTS ONLY) WITH A DIAGNOSIS OF ASTHMA AS DEFINED BY THE NATIONAL INSTITUTES OF HEALTH [NIH, 2007], AT LEAST 12 WEEKS PRIOR TO VISIT 1.
•NOTE: TARGET TO RANDOMISE APPROXIMATELY 12 % OF SUBJECTS AGED 12-17 YEARS.
•3. GENDER: MALE OR ELIGIBLE FEMALE, DEFINED AS 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.
•INJECTABLE PROGESTOGEN.
•ORAL CONTRACEPTIVE (EITHER COMBINED ESTROGEN/PROGESTIN OR PROGESTIN ONLY).
•ANY INTRAUTERINE DEVICE (IUD) WITH A DOCUMENTED FAILURE RATE OF LESS THAN 1% PER YEAR.

•1. 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 10 YEARS.
•2. RESPIRATORY INFECTIONS: CULTRE 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 THE INVESTIGATOR, IS EXPECTED TO AFFECT THE SUBJECT´S ASTHMA STATUS OR THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY.
•3. ASTHMA EXACERBATION: ANY ASTHMA EXACERBATION WITHIN 12 WEEKS OF VISIT 1 REQUIRING ORAL CORTICOSTEROIDS OR THAT RESULTED IN OVERNIGHT HOSPITALISATION REQUIRING ADDITIONAL TREATMENT FOR ASTHMA WITHIN 6 MONTHS PRIOR TO VISIT 1.
•4. CONCURRENT RESPIRATORY DISEASE: A SUBJECT MUST NOT HAVE CURRENT EVIDENCE OF PNEUMONIA, PNEUMOTHORAX, ATELECTASIS, PULMONARY FIBROTIC DISEASE, BRONCHOPULMONARY DYSPLASIA, CHRONIC BRONCHITIS, EMPHYSEMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, OR OTHER RESPIRATORY ABNORMALITIES OTHER THAN ASTHMA.

发起方

GLAXOSMITHKLINE PERU S.A.,