None listed
Conditions
Interventions
THIS STUDY WILL BE CONDUCTED AT APPROXIMATELY 700 CENTERS IN APPROXIMATELY 25 COUNTRIES. EACH SITE WILL RECRUIT AN ESTIMATED 12-20 PATIENTS. ELEVEN THOUSAND SEVEN HUNDRED (11,700) MALE AND FEMALE PAT
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.).
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Korea South, Mexico, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Thailand, Ukraine, United Kindgdom, United States, Vietnam
Outcome results
None listed