SAS115359, A SAFETY AND EFFICACY STUDY OF INHALED FLUTICASONE PROPIONATE/SALMETEROL COMBINATION VERSUS INHALED FLUTICASONE PROPIONATE IN THE TREATMENT OF ADOLESCENT AND ADULT SUBJECTS WITH ASTHMA

GlaxoSmithKline,0 个研究点目标入组 144 人开始时间: 2013年1月28日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. INFORMED CONSENT:
•THE SUBJECT AND/OR THE SUBJECT´S LEGAL GUARDIAN (IF APPLICABLE) MUST PROVIDE WRITTEN INFORMED ASSENT/CONSENT TO TAKE PART IN THE STUDY.
•SUBJECTS AND/OR THEIR LEGAL GUARDIANS (IF APPLICABLE) UNDERSTAND THAT THEY MUST COMPLY WITH STUDY TREATMENT AND STUDY ASSESSMENTS INCLUDING RECORDING OF DAILY INFORMATION REGARDING THEIR ASTHMA STATUS AND ATTEND SCHEDULED STUDY VISITS, AND BE ACCESSIBLE BY TELEPHONE.
•2. SUBJECT: 12 YEARS OF AGE AND OLDER.
•3. GENDER: MALE OR FEMALE.
•4. ASTHMA DIAGNOSIS: PERSISTENT ASTHMA, DEFINED BY NATIONAL AND INTERNATIONAL ASTHMA GUIDELINES [GINA, 2009; NIH, 2007; ETC.] FOR AT LEAST 1 YEAR PRIOR TO STUDY ENROLMENT. IF THE SUBJECT IS NAÏVE TO THE STUDY SITE, THE DIAGNOSIS OF ASTHMA MUST BE CONFIRMED BY SUBJECT HISTORY.
•NOTE: INVESTIGATORS MUST USE APPROPRIATE MEANS TO ENSURE THE SUBJECT´S ASTHMA
•DIAGNOSIS (E.G., SUBJECT HISTORY, PHARMACY RECORDS, OR CHART RECORDS, ETC.).
•5. PEF: A CLINIC PEF ≥ 50% OF PREDICTED NORMAL VALUE. PERCENT PREDICTED PEF VALUES MUST BE CALCULATED USING NHANES III WITH RELEVANT EQUATIONS THAT ADJUST FOR RACE AND NATIONAL ORIGIN. [HANKINSON, 1999; HANKINSON, 2010].

•1. HISTORY OF LIFE-THREATENING ASTHMA: DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBATION AND/OR WAS ASSOCIATED WITH HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT.
•2. CONCURRENT RESPIRATORY DISEASE: SUBJECTS WITH CURRENT EVIDENCE OF PNEUMONIA, PNEUMOTHORAX, ATELECTASIS, PULMONARY FIBROTIC DISEASE, ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS, CYSTIC FIBROSIS, BRONCHOPULMONARY DYSPLASIA, OR OTHER RESPIRATORY ABNORMALITIES OTHER THAN ASTHMA.
•3. CHRONIC OBSTRUCTIVE PULMONARY DISEASE: SUBJECTS WITH CURRENT EVIDENCE OF, OR EVER BEEN TOLD BY A PHYSICIAN THAT THEY HAVE CHRONIC BRONCHITIS, EMPHYSEMA, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
•4. TOBACCO USE: HISTORY OF SMOKING > 10 PACK YEARS (NUMBER OF PACK YEARS (NUMBER OF CIGARETTES PER DAY/20) X NUMBER OF YEARS SMOKED).
•5. EXERCISE-INDUCED ASTHMA: SUBJECTS WITH EXERCISE INDUCED ASTHMA (AS THE ONLY ASTHMA-RELATED DIAGNOSIS) NOT REQUIRING DAILY ASTHMA CONTROL MEDICINE.
•6. RESPIRATORY INFECTION: CULTURE-DOCUMENTED OR SUSPECTED BACTERIAL OR VIRAL INFECTION OF THE UPPER OR LOWER RESPIRATORY TRACT, SINUS OR MIDDLE EAR THAT IS NOT RESOLVED AT RANDOMIZATION.

发起方

GlaxoSmithKline,