None listed
Conditions
Interventions
PERIOD I: PRE-STUDY PERIOD. SUBJECTS RECEIVING IC S/LABA WILL BE REQUIRED TO DISCONTINUE THE LABA (WHILE STILL RECEIVING THE ICS COMPONENT) DURING THIS PERIOD.
PERIOD II: 2- TO 4-WEEK RUN-IN PERIOD
(2) MATCHING-IMAGE PLACEBO FOR MK-1029 PLUS MONTELUKAST (GROUP 2).
PERIOD IV: 4-WEEK SINGLE-BLIND WASHOUT PERIOD WHERE ALL SUBJECTS RECEIVE MATCHING-IMAGE PLACEBO FOR MK-1029 PLUS MONTELUKAST 10 MG
(2) MATCHING-IMAGE PLACEBO FOR MK-1029 PLUS MONTELUKAST (GROUP 1). SUBJECTS PREVIOUSLY ASSIGNED TO MK-1029 WILL RECEIVE MK-1029 MATCHING-IMAGE PLACEBO (GROUP 1) AND SUBJECTS PREVIOUSLY ASSIGNED TO MK-
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: VISIT 1 1. SUBJECT IS A FEMALE OR MALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE. 2. SUBJECT IS NOT PREGNANT (AS EVIDENCED BY NEGATIVE SERUM PREGNANCY TEST FOR SUBJECTS OF CHILDBEARING POTENTIAL) OR BREASTFEEDING AND DOES NOT PLAN TO BECOME PREGNANT FOR THE DURATION OF THE STUDY AND POST STUDY FOLLOW-UP PERIOD. 3. A SUBJECT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL WITHIN THE PROJECTED DURATION OF THE STUDY. ACCEPTED METHODS OF BIRTH CONTROL ARE: INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONTRACEPTIVE SPONGE, CONDOM, VASECTOMY, HORMONAL CONTRACEPTIVES. A FEMALE SUBJECT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS ELIGIBLE WITHOUT REQUIRING THE USE OF CONTRACEPTION. A FEMALE SUBJECT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS DEFINED AS: ONE WHO HAS EITHER 1) REACHED NATURAL MENOPAUSE (DEFINED AS 6 MONTHS OF SPONTANEOUS AMENORRHEA WITH SERUM FSH LEVELS IN THE POSTMENOPAUSAL RANGE AS DETERMINED BY THE LABORATORY, OR 12 MONTHS OF SPONTANEOUS AMENORRHEA), 2) 6 WEEKS POST SURGICAL BILATERAL OOPHORECTOMY WITH OR WITHOUT HYSTERECTOMY, OR 3) BILATERAL TUBAL LIGATION.
Exclusion criteria
Exclusion criteria: VISIT 1 1. SUBJECT IS, IN THE OPINION OF THE INVESTIGATOR, MENTALLY OR LEGALLY INCAPACITATED PREVENTING INFORMED CONSENT FROM BEING OBTAINED, UNABLE TO READ OR COMPREHEND WRITTEN MATERIAL, OR UNABLE TO COMPLY WITH THE STUDY PROCEDURES OR PROTOCOL. 2. SUBJECT HAS A RECENT HISTORY (≤ 3 MONTHS) OF MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, OR UNCONTROLLED CARDIAC ARRHYTHMIA PRIOR TO VISIT 1. 3. SUBJECT IS HOSPITALIZED OR HAS BEEN HOSPITALIZED IN THE 4 WEEKS PRIOR TO VISIT 1. 4. SUBJECT INTENDS TO MOVE OR ANTICIPATES MISSING ANY CLINIC VISIT DAYS. 5. SUBJECT HAS UNDERGONE ANY MAJOR SURGICAL PROCEDURE WITHIN 4 WEEKS PRIOR TO VISIT 1. 6. SUBJECT HAS PARTICIPATED IN A CLINICAL TRIAL INVOLVING AN INVESTIGATIONAL DRUG WITHIN THE 4 WEEKS PRIOR TO VISIT 1. 7. SUBJECT IS CURRENTLY A REGULAR USER OR A RECENT PAST ABUSER (WITHIN THE PAST 5 YEARS) OF ALCOHOL (> 14 DRINKS/WEEK) OR ILLICIT DRUGS. 8. SUBJECT HAS DONATED A UNIT OF BLOOD WITHIN 2 WEEKS PRIOR TO VISIT 1 OR INTENDS TO DONATE A UNIT OF BLOOD AT ANY TIME DURING THE COURSE OF THIS STUDY. PULMONARY 9. SUBJECT HAS EVIDENCE OF ANOTHER CLINICALLY SIGNIFICANT, ACTIVE PULMONARY DISORDER SUCH AS BRONCHIECTASIS OR COPD DOCUMENTED BY HISTORY, PHYSICAL EXAMINATION, OR CHEST X-RAY.
Countries
Canada, Colombia, Germany, Peru, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed