None listed
Conditions
Interventions
SUBJECTS MEETING ALL OF THE NCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA AT THE SCREENING VISIT (VISIT 1) WILL ENTER A FOUR WEEK RUN-IN PERIOD DURING WHICH TIME THEY WILL CONTINUE THEIR CURREN
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
5 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. INFORMED CONSENT: WRITTEN INFORMED CONSENT FROM AT LEAST ONE PARENT/CARE GIVER AND ACCOMPANYING INFORMED ASSENT FROM THE SUBJECT (WHERE THE SUBJECT IS ABLE TO PROVIDE ASSENT) PRIOR TO ADMISSION TO THE STUDY. • IF APPLICABLE, SUJECT MUST BE ABLE AND WILLING TO GIVE ASSENT TO TAKE PART IN THE STUDY ACCORDING TO THE LOCAL REQUERIMENT. THE STUDY INVESTIGATOR IS ACCOUNTABLE FOR DETERMINING A HILD´S CAPACITY TO ASSENT TO PARTICIPATION IN A RESEARCH STUDY, TAKING INTO CONSIDERATION ANY STANDARDS SET BY THE RESPONSIBLE IEC/IRB. • SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THE STUDY REQUIRES THEM TO BE TREATED ON AN OUTPATIENT BASIS. • SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THEY MUST COMPLY WITH STUDY ASSESSMENT INCLUDING RECORDING OF SYMPTOM SCORE AN RESCUE ALBUTEROL/SALBUTAMOL USE, ATTENDING SCHEDULED STUDY VISITS, AND BEING ACCESSIBLE BY A TELEPHONE CALL. 2. AGE: 5-11 YEARS AT VISIT 1. 3. GENDER: MALE AND PRE-MENARCHIAL FEMALES ARE DEFINED AS ANY FEMALE WHO HAS YET TO BEGIN MENSES.
Exclusion criteria
Exclusion criteria: 1. LIFE THREATENING ASTHMA: SUBJECTS WITH A HISTORY OF LIFE-THREATENING ASTHMA, DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INCUBATION, HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT, RESPIRATORY ARREST, HYPOXIC SEIZURES OR ATHSMA-RELATED SYNCOPAL EPISODE(S). 2. ASTHMA EXACERBATION: SUBJECTS WITH A HISTORY OF ASTHMA EXACERBATION REQUIRING THE USE OF SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION, OR INJECTION) FOR AT LEAST 3 DAYS OR A DEPOT CORTICOSTEROID INJECTION OR REQUIRING HOSPITALIZATION FOR ASTHMA (WITHIN 6 MONTHS) PRIOR TO SCREENING. 3. CONCOMITANT MEDICATIONS: SUBJECTS CURRENTLY RECEIVING (OR HAVE RECEIVED WITHIN 4 WEEKS OF SCREENING) ASTHMA THERAPIES INCLUDING THEOPHYLLINES, LONG-ACTING INHALED BETA-AGONISTS, OR WHO HAVE CHANGED THEIR ASTHMA MEDICATION WITHIN 4 WEEKS OF SCREENING. CONCOMITANT MEDICATION: USE OF THE FOLLOWING MEDICATIONS IN PROHIBITED ACCORDING TO THE TIMEFRAMES BELOW.
Countries
Bulgaria, Germany, Japan, Mexico, Peru, Philippines, Poland, Russian Federation, Sweden, United States
Contacts
Public ContactRosa Elvira Velasquez
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed