A 26-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, ACTIVE CONTROLLED, MULTICENTER, MULTINATIONAL SAFETY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS DURING TREATMENT WITH SYMBICORT® , A FIXED COMBINATION OF INHALED CORTICOSTEROID (ICS) (BUDESONIDE) AND A LONG ACTING ß2 - AGONIST (LABA)(FORMOTEROL) AS COMPARED TO TREATMENT WITH ICS (BUDESONIDE) ALONE IN ADULT AND ADOLESCENT (≥ 12 YEARS OF AGE) PATIENTS WITH ASTHMA.

ASTRAZENECA PERU S.A.,0 个研究点目标入组 188 人开始时间: 2012年2月17日最近更新: 2023年9月4日

研究概览

暂无简介。

•1. PROVISION OF SIGNED INFORMED CONSENT/PAEDIATRIC ASSENT (IF APPLICABLE) PRIOR TO ANY STUDY SPECIFIC PROCEDURES INCLUDING MEDICATION WITHDRAWAL. NB: PATIENTS AGREEING TO PARTICIPATE IN THE OPTIONAL EXPLORATORY GENETIC RESEARCH MUST PROVIDE A SEPARATE INFORMED CONSENT.
•2. MALE OR FEMALE, ≥ 12 YEARS OF AGE.
•3. DOCUMENTED CLINICAL DIAGNOSIS OF ASTHMA AS DEFINED BY NATIONAL AND INTERNATIONAL ASTHMA GUIDELINES (ie, NAEPP EPR-3 2007, GINA, ATS/ERS, ETC.) FOR AT LEAST 1 YEAR PRIOR TO VISIT 2.
•4. PATIENT MUST HAVE HISTORY OF AT LEAST 1 ASTHMA EXACERBATION INCLUDING ONE THE FOLLOWING:
•- REQUIRING TREATMENT WITH SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION, OR INJECTABLE) BETWEEN 4 WEEKS AND 12 MONTHS PRIOR TO RANDOMIZATION
•- AN ASTHMA RELATED HOSPITALIZATION (DEFINED AS AN INPATIENT STAY OR > 24 HOURS STAY IN OBSERVATION AREA IN ER OR OTHER EQUIVALENT FACILITY DEPENDING ON THE COUNTRY AND HEALTH CARE SYSTEM) BETWEEN 4 WEEKS AND 12 MONTHS PRIOR TO RANDOMIZATION.
•NB: THE INVESTIGATORS MUST USE THE APPROPRIATE MEANS TO ENSURE THE ACCURACY OF THE HISTORY OF SUBJECT EXACERBATIONS (EG., PATIENT HISTORY, RECORDS OF PHARMACY, HOSPITAL RECORDS SHEET OR CLINIC, ETC.).

•1. HAS A HISTORY OF LIFE-TREATENING ASTHMA. DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBACION AND/OR WAS ASSOCIATED WITH HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT.
•2. HAS REQUIRED TREATMENT WITH SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION, OR INJECTABLE) FOR ANY REASON WITHIN 4 WEEKS PRIOR TO VISIT 2.
•3. HAS A ONGOING EXACERBATION, DEFINED AS A WORSENING OF ASTHMA THAT REQUIRES TREATMENT WITH SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION, OR INJECTABLE).
•4. ASTHMA EXACERBATION:
•- ANY ASTHMA EXACERBATION REQUIRING SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION OR INJECTION) WITHIN 4 WEEKS OF RANDOMIZATION OR MORE THAN 4 SEPARATE EXACERBATIONS IN THE 12 MONTHS PRECEDING RANDOMIZATION. FOR EXACERBATIONS TO BE CONSIDERED SEPARATE EVENTS THERE MUST BE AT LEAST 7 DAYS FROM THE RESOLUTION OF ONE EXACERBATION TO THE START OF THE SECOND EXACERBATION.
•NB: INVESTIGATORS SHOULD USE CLINICAL JUDGMENT AND CONSIDER THE SUBJECTS HISTORY OF EXACERBATION, INCLUDING THE SEVERITY AND INTERVAL SINCE THE LAST EXACERBATION PER CURRENT CLINICAL GUIDELINES, IN DETERMINING WHETHER A SUBJECT WITH MULTIPLE EXACERBATIONS IN THE PRIOR YEAR SHOULD BE ENROLLED IN THE STUDY.

发起方