RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF A MONTELUKAST INHALED CORTICOSTEROID COMPARED TO THERAPY WITH A INHALED CORTICOSTEROID ONLY, IN PATIENTS WITH CHRONIC ASTHMA
- Conditions
- J45-J45
- Registration Number
- PER-029-08
- 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 an outpatient of female or male between 15 and 85 years of age.
• The patient is not pregnant (as evidenced by a serum pregnancy test with a negative result in the case of potentially fertile patients) or is not breastfeeding, and does not plan to become pregnant during the entire study and the post-study follow-up period.
• The patient is highly unlikely to conceive as indicated by, at least, a yes response
• The patient has a consistent clinical history, for a minimum of 1 year, of chronic asthma symptoms that may include, without limitation, dyspnea, wheezing, chest tightness, cough, and / or sputum production.
• The patient has received treatment with an immediate-action inhaled p-agonist, and may have received treatment with an inhaled corticosteroid (ICS) at any dose, or a combination therapy of ICS and a long-acting beta-agonist (LABA) at any dosage, during the 4 weeks prior to Visit 1.
• The patient has not smoked for a minimum of 1 year, and has a history of having smoked no more than 7 pack-years (ie, 1 pack [20 cigarettes] per day for 7 years).
• The patient can maintain a constant cycle of day / night, wakefulness / sleep.
• The patient agrees not to change their usual consumption of caffeinated beverages throughout the study.
• The patient has a Body Mass Index (BMI) between 19 and 35 kg / m2 inclusive (BMI = weight in kg / [height in meters] 2)
• The patient is, in the opinion of the researcher, mentally or legally disabled, which prevents the obtaining of informed consent, can not read or understand written material, or does not have the capacity to comply with the study procedures or protocol.
• The patient is hospitalized or has been hospitalized for 4 weeks prior to Visit 1.
• The patient intends to move or take a vacation away from home (for> 5 days) in the course of the study.
• The patient has undergone some major surgical procedure within 4 weeks prior to Visit 1.
• The patient has participated in a clinical trial that involves a research drug within 4 weeks prior to Visit 1.
• The patient is currently a regular user of alcohol or illicit drugs, or has recently suffered (within the last 5 years) of alcoholism (> 14 doses / week) or drug addiction.
• The patient 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.
• The patient presents evidence of another clinically significant active pulmonary disorder, such as bronchiectasis or COPD, documented by medical history, physical examination, or chest x-ray.
• The patient has received treatment in an emergency room due to asthma within 4 weeks of Visit 1 or has been hospitalized due to asthma within 2 months prior to Visit 1.
• The patient has had a respiratory tract infection that required treatment with antibiotics within 2 months prior to Visit 1 or an airway infection that did not require treatment with antibiotics (eg, viral) within 4 weeks prior to Visit 1.
• The patient presents evidence of an active, clinically significant sinus disease within 1 week prior to Visit 1.
• The patient is not able to perform an acceptable reproducible spirometry.
• The patient has a recent history (within 3 months of Visit 1) of a clinically significant psychiatric disorder, different from stable depression.
• The patient is hypersensitive to inhaled P agonists, corticosteroids, leukotriene antagonists, or any of its components.
• The patient has a history of malignancy <5 years before the signing of the informed consent, with the exception of basal cell or squamous cell carcinoma of the skin or cervical cancer of the cervix properly treated.
• The patient has a recent history (<3 months) of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia before Visit 1; or uncontrolled hypertension, defined as systolic pressure> 160 mmHg and / or diastolic> 100 mmHg, during at least 2 of the first 3 study visits (Visit 1, Visit 2 and Visit 3); or a screening electrocardiogram (ECG) that demonstrates a clinically significant or unexplained abnormality.
• The patient has a clinically unstable disease or a recent clinical history of the ophthalmological, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematological systems (including immunodeficiency).
• The patient has a history of any disease that may require treatment with an excluded drug, could threaten his life immediately (eg, ventricular arrhythmia), pose a restriction on participation or successful completion of the test, or pose an additional risk to the patient. patient when receiving the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method