None listed
Conditions
Interventions
THE STUDY WILL RANDOMIZE APPROXIMATELY 6,200 SUBJECTS WITH ADEQUATE REPRESENTATION THROUGHOUT THE AGES OF 4 TO 11 YEARS.
POTENTIAL SUBJECTS WILL BE SCREENED AT VISIT 1 TO ASSESS ELIGIBILITY. AT VIS
Sponsors
GlaxoSmithKline,
Eligibility
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. INFORMED CONSENT: • SUBJECT´S LEGAL GUARDIAN MUST BE ABLE AND WILLING TO GIVE WRITTEN INFORMED CONSENT TO TAKE PART IN THE STUDY. IF APPLICABLE, SUBJECT MUST BE ABLE AND WILLING TO GIVE ASSENT TO TAKE PART IN THE STUDY ACCORDING TO THE LOCAL REQUIREMENT. • 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 MEDICATION AND STUDY ASSESSMENTS INELUDING RECORDING OF SYMPTOM SCORES AND RESCUE ALBUTEROL/SALBUTAMOL USE, ATTENDING SCHEDULED STUDY VISITS, AND BEING ACCESSIBLE BY A TELEPHONE CALL. 2. AGE: 4-11 YEARS OF AGE AT VISIT 1. 3. GENDER: MALE OR ELIGIBLE FEMALE FEMALE SUBJECTS SHOULD NOT BE ENROLLED IF THEY ARE PREGNANT, LACTATING OR PLAN TO BECOME PREGNANT DURING THE TIME OF STUDY PARTICIPATION. ALL FEMALES OF CHILDBEARING POTENTIAL MUST HAVE A NEGATIVE URINE PREGNANCY TEST RESULT PRIOR TO RANDOMIZATION TO CONTINUE IN THE STUDY. FEMALES WHO BECOME PREGNANT DURING THE COURSE OFTHE STUDY WILL BE DISCONTINUED AND THE PREGNANCY OUTCOME FOLLOWED (SEE SECTION 6.2.5) FEMALES OF CHILDBEARING POTENTIAL ARE
Exclusion criteria
Exclusion criteria: 1. HISTORY OF LIFE-THREATENING ASTHMA: DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBATION, HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT, RESPIRATORY ARREST, HYPOXIC SEIZURES OR ASTHMA-RELATED SYNCOPAL EPISODE(S). 2. UNSTABLE ASTHMA AT VISIT 1. SIGNS OF UNSTABLE ASTHMA INCLUDE: • DAILY USE OF > 4 PUFFS OF ALBUTEROL/SALBUTAMOL (OTHER THAN PRE-EXERCISE TREATMENT), ≥ 8 PUFFS OF ALBUTEROL/SALBUTAMOL FOR 2 OR MORE CONSECUTIVE 24-HOUR PERIODS IN THE 7 DAYS PRECEDING VISIT 1, • ≥ 2 NIGHTTIME AWAKENINGS DUE TO ASTHMA SYMPTOMS IN THE 7 DAYS PRECEDING VISIT 1, OR • INVESTIGATOR´S DISCRETION (REASON SHOULD BE RECORDED IN SOURCE DOCUMENTS). 3. SUBJECTS WHO ARE CURRENTLY RECEIVING HIGH-DOSE ICS OR ICS/LABA THERAPY TO TREAT ASTHMA SYMPTOMS. 4. CONCURRENT RESPIRATORY DISEASE: CURRENT EVIDENCE OF PNEUMONIA, PNEUMOTHORAX, ATELECTASIS, PULMONARY FIBROTIC DISEASE, ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS, CYSTIC FIBROSIS, BRONCHOPULMONARY DYSPLASIA, OR OTHER SEVERE RESPIRATORY ABNORMALITIES OTHER THAN ASTHMA.
Countries
United States
Contacts
Public ContactYngrid Rossana Saldarriaga Toledo
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed