None listed
Conditions
Interventions
SUBJECT ELIGIBILITY WILL BE ASSESSED AT THE SCREENING AND BASELINE VISITS (VISIT 1 AND VISIT 2). THE BASELINE VISIT (VISIT 2) MAY OCCUR ON THE SAME DAY AS VISIT 1 OR UP TO 14 DAYS AFTER VISIT 1, IF NE
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Eligibility
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. THE SUBJECT(AND PARENT/GUARDIAN FOR A SUBJECT UNDER THE AGE OF LEGAL CONSENT) MUST BE WILLING TO GIVE WRITTEN INFORMED CONSENT/ASSENT AND BE ABLE TO ADHERE TO DOSE AND VISIT SCHEDULES. 2. A SUBJECT OF EITHER SEX, AND ANY RACE, MUST BE ≥ 12 YEARS OF AGE AT THE SCREENING VISIT (VISIT 1). 3. A SUBJECT MUST REPORT USING ONE OF THE FOLLOWING ASTHMA THERAPIES AND MEET THE ASSOCIATED REQUERIMENTS DEFINED BELOW: . ICS OR ICS WITH ONE OR MORE ADJUNCTIVE THERAPIES (LABA, LTRA OR THEOPHYLLINE) AT A STABLE DOSE FOR AT LEAST 4 WEEKS PRIOR TO RANDOMIZATION. NOTE: SUBJECTS MAINTAINED ON A STABLE HIGH DOSE ICS WITH OR WHITOUT ONE OR MORE ADJUNCTIVE THERAPIES (LABA, LTRA OR THEOPHYLLINE) MUST HAVE AN ACQ-6 TOTAL SCORE < 1.5 (CONTROLLED) AT THE SCREENING VISIT. (SEE TABLE 2: FOR ICS DOSE DEFINITIONS). . LEUKOTRIENE RECEPTOR ANTAGONIST (I.E. LTRAS SUCH AS MONTELUKAST, ZAFIRLUKAST, OR PRANLUKAST) OR XANTHINES (E.G. THEOPHYLLINE) AS MONOTHERAPY AT A STABLE DOSE FOR AT LEAST 4 WEEKS PRIOR TO RANDOMIZATION. NOTE: SUBJECTS ON LTRAS, OR XANTHINES, ARE ELIGIBLE ONLY IF THEY RECORD AN ACQ-6 TOTAL SCORE OF ≥ 1.5 AND IN THE INVESTIGATOR´S CLINICAL JUDGMENT, THE SUBJECT´S ASTHMA SEVERITY COULD JUSTIFY TREATMENT WITH ICS ±LABA.
Exclusion criteria
Exclusion criteria: 1. A SUBJECT WITH UNSTABLE ASTHMA. SUBJECTS WHO MEET ANY OF THE FOLLOWING CRITERIA (BASED ON THE 7 DAYS PRIOR TO RANDOMIZATION), DESPITE ADEQUATE DOSING TECHNIQUE, ADHERENCE TO PRESCRIBED ASTHMA MEDICATION, AND APPROPRIATE USE OF RESCUE MEDICATION, ARE DEEMED UNSTABLE: • ASTHMA SYMPTOMS THAT PERSISTS THROUGHOUT THE DAY ON 2 CONSECUTIVE DAYS; • NIGHTTIME AWAKENING DUE TO ASTHMA ≥ 3 NIGHTS IN A WEEK; • ALBUTEROL/SALBUTAMOL RESCUE USE (NOT FOR PREVENTION OF EIB) > 8 PUFFS/DAY FOR 2 CONSECUTIVE DAYS OR ≥ 25 PUFFS IN ONE DAY; . NOTE: PROPHYLACTIC USE OF ALBUTEROL/SALBUTAMOL IS PERMITTED, AT THE JUDGMENT OF THE INVESTIGATOR, WHEN PREVIOUSLY PRESCRIBED FOR EIB. HOWEVER, SABA SHOULD NOT BE OTHERWISE TAKEN IN ANTICIPATION OF ASTHMA SYMPTOMS. • ASTHMA SYMPTOMS SO SEVERE THAT THE SUBJECT WAS LIMITED IN THEIR ABILITY TO PERFORM NORMAL DAILY ACTIVITIES; NOTE: SUBJECTS DEEMED UNSTABLE MAY NOT BE RANDOMIZED. AT THE JUDGMENT OF THE INVESTIGATOR, SUBJECTS MAY BE RESCREENED ONCE PER CALENDAR YEAR (I.E., APPROXIMATELY EVERY 52 WEEKS), AFTER WAITING AT LEAST 4-WEEKS FROM THE INITIAL SCREENING DATE. 2. A SUBJECT WITH COPD, CYSTIC FIBROSIS (CF), OR OTHER SIGNIFICANT, NON-ASTHMATIC, LUNG DISEASE.
Countries
Australia, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, Germany, Hungary, Ireland, Israel, Korea North, Malasya, Mexico, Poland, Romania, Slovakia, South Africa, Spain, United Kindgdom, United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed