A DOUBLE BLIND, RANDOMIZED, CONTROLLED WITH PLACEBO, MULTICENTER, PARALLEL GROUPS, STUDY OF THE DETERMINATION OF THE DOSE RANGE OF MK-0633 PERFORMED IN ADULT PATIENTS WITH CHRONIC ASTHMA
- Conditions
- -J45J45
- Registration Number
- PER-092-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is a woman or man between 18 and 65 years of age who receives outpatient care.
• The patient is not pregnant (as evidenced by a pregnancy test in urine with a negative result in potentially fertile patients) and is not breastfeeding and does not plan to become pregnant during the entire study and the post-study follow-up period.
• It is highly unlikely that the patient can conceive how at least one yes answer indicates the following questions: The patient is a man, The patient is a surgically sterilized woman (6 weeks after bilateral oophorectomy surgery) with or without hysterectomy, or bilateral tubal ligation). The patient is a postmenopausal woman. The postmenopausal status is defined as> 43 years of age and 1) absence of menstruation for> 6 months and confirmed by elevated FSH levels in the postmenopausal range (as defined by the designated Central Laboratory) or 2) absence of menstruation for> 12 months months
• The patient is an unsterilized premenopausal woman who is not active heterosexually (and who does not plan to become heterosexually active during the course of the study) and who agrees to use 2 appropriate barrier contraceptive methods to prevent pregnancy throughout the study beginning with the Visit 1 and up to 14 days after the last dose of the study drug (see Section 3.2.2.3 for a description of acceptable contraceptive methods).
• The patient has a consistent clinical history, for a minimum of 1 year, of chronic asthma symptoms that may include, without limitation, dyspnea, wheezing, tightness in the chest, cough, and / or production of sputum.
• The asthma treatment of the patient must fall into one of the following two categories: 5.1 The patient must have been receiving a stable dose of IGS or the combination of ICS / LABA (any dose) during a minimum of 4 weeks before Visit 1 and should maintain this dose throughout the study (approximately 2/3 of the study patients); OR 5.2 The patient should have been using only immediate-acting inhaled p-agonists (albuterol / salbutamol) on demand and not ICS or a combination of CS / LABA (approximately 1/3 of study patients).
• The patient has never smoked or smoked for a minimum of 1 year, with a history of having smoked no more than 7 packs per year (ie, 1 pack [20 cigarettes] per day for 7 years).
• The patient is able to maintain a constant day / night, wakefulness / sleep cycle.
• The patient agrees not to change their habitual consumption of drinks with caffeine during the entire study.
• The patient has a Body Mass Index (BMI) between 19 and 35 kg / m2 inclusive (BMI, weight in kg / [height in meters]
• The patient, in the opinion of the investigator, is mentally or legally incapacitated, which prevents their informed consent from being obtained, is not able to read
• The patient has a history of any disease that could require treatment with an excluded drug, could immediately threaten his life (for example, ventricular arrhythmia, neoplasia, [incompletely cured or treated in the last 3 months], poorly controlled diabetes mellitus ), could represent a restriction in the participation or successful completion of the test, or could pose an additional risk to the patient to whom the study drug is administered.
• The electrocardiogram (ECG) in the screening demonstrates a clinically significant or unexplained abnormality, which may include, without a limiting sense: a clinically significant conduction disorder (eg, second- or third-degree AV block), a clinically significant tachycardia, an active cardiac ischemia, or a QTc> 460msec.
• The patient presents documented albumin at a level of> 1 g of albumin per day (as estimated by the albumin / creatinine ratio> 1).
• The patient has used drugs with known activities as strong inhibitors or inducers of the metabolism of P-450 (for example, phenobarbital, phenoltoin, rifampin, ltrimethoprim, sulfamethoxazole, and ketoconazole [or other azoles]), within the 2 weeks prior to the Visit, 1 (Appendix 6.9), or plan to take such drugs during the study.
• The patient has used any drug with a limited therapeutic index (eg, Warfarin, Coumadin, Dicpumaroi, Digoxin, Digitoxin) within 2 weeks prior to Visit 1 or plans to take such drugs during the study.
• The patient has used any of the following antiasthmatic drugs or plans to take such drugs during the study:
• Inhaled long-acting or immediate anticholinergic agents within 2 weeks prior to Visit 1;
• Inhaled corticosteroids within 4 weeks prior to Visit 1 and the patient is part of 1/3 of patients who use only immediate-action p-agonists on demand during the study;
• Oral, intravenous, intramuscular or rectal corticosteroids within 4 weeks prior to Visit 1;
• LABA oral or inhaled within 1 week prior to Visit 1 and the patient is part of 1/3 of patients who use only immediate-action p-agonists on demand during the study;
• Xanthine derivatives or combinations with xanthine within 2 weeks prior to Visit 1;
• Leukotriene receptor antagonists or inhibitors of leukotriene synthesis within 2 weeks prior to Visit 1;
• Omalizumab within 4 weeks prior to Visit 1.
• Aspirin and nonsteroidal anti-inflammatory drugs in patients known to be sensitive or patients who have not had prior exposure to these compounds.
• The patient has begun an immunotherapy within 6 months prior to visit 1. If immunotherapy is being performed, the patient should be kept on a stable dose of immunotherapy throughout the study.
• The patient has used any potentially nephrotoxic drug within 2 weeks before Visit 1 or plans to take such drugs during the study.
• The patient is not able to comply with the study procedures or protocol, including filling out the diary card and compliance with the study drug.
• The patient is not able to perform an acceptable, reproducible spirometry.
• The patient has needed a rescue with corticosteroids due to a worsening of asthma between Visit 1 and Visit 2.
• The patient is not able to comply with the study procedures or protocol, including filling out the diary card and co
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method