None listed
Conditions
Interventions
Period II Montelukast Type of group
10 mg / day of montelukast orally plus Placebo of fluticasone for 12 weeks
Group name:Period III Montelukast Type of group
10% of patients who received 200 ug / day of fluticasone + Placebo of montelukast will now receive 10 mg / day of montelukast orally for 36 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient understands the study procedures and agrees to participate by signing the respective informed consent form. • The patient is a man or woman who is at least 15 and not more than 85 years old at Visit 1. • The patient complies with all the signs and symptoms of asthma listed below in Visit 3: o History diagnosed by a doctor, of at least four months duration, of intermittent or persistent symptoms including, but not limited to, dyspnea, wheezing, chest tightness, cough or sputum production. o One forced expiratory volume in one second (VEFi), while the p-agonist is suspended for at least six hours, at least 80% of the value foreseen in Visit 1 or 2, and also in Visit 3. o Evidence of reversible airway obstruction, as defined by an increase in VEFi or peak expiratory flow (PEFR) of> 12% (absolute value), 20 to 30 minutes after inhaled beta-agonist administration by at least once on Visits 1, 2, 3 or within the previous 4 weeks, OR a methacholine / histamine PC20 (provocation concentration causing a decrease in VEFj of 20%) of 2 and <5 days a week between Visits 2 and 3 (both for symptoms and use of p-agonists). • The patient´s current asthma treatment includes only short-acting inhaled p-agonists. • The patient currently does not smoke and has not smoked for at least six months prior to Visit i, with a history of smoking of no more than fifteen pack-years [ie, one cigarette (20 cigarettes) per day for fifteen years ] • The patient is considered to have a good and stable physical and mental health status (except for his asthma) based on the medical history, physical examination and routine laboratory data, and apparently is able to satisfactorily complete this test.
Exclusion criteria
Exclusion criteria: General character • The patient does not have the legal age allowed and the consent of the parent or guardian can not be obtained. • The patient, in the opinion of the investigator, is mentally or legally incapacitated, which prevents informed consent from being obtained, or unable to read or understand the written material. • The patient is hospitalized. • The patient is a woman who has 7 days in the 4 weeks prior to Visit 1 (chronic antibiotics taken for acne will be allowed). Pulmonary • The patient, in addition to asthma, has suffered active, acute or chronic pulmonary disorders documented in his or her history or physical examination. • The patient has been treated in an emergency room within a month or has been hospitalized for asthma within three months of the visit • The patient has unresolved symptoms and signs of upper respiratory tract infection (URI) within three weeks of Visit 1 or during the onset period. • The patient presents evidence of clinically significant active sinus infection (if he had it previously, he must have gone down within a week of Visit 1). General medicine • The patient has a recent history (within three months of the start of the study) of a clinically significant psychiatric disorder other than mild depression (does not interfere with their work or social activities). • The patient has a history of an anaphylactic allergic reaction that is related to the administration of a commercialized or experimental drug, or is otherwise hypersensitive to inhaled p-agonist, inhaled or oral corticosteroid or its components. • The patient has a clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or has uncontrolled hypertension (> 160/95). • The patient has a history of any disease that would require treatment with an excluded medicine, could represent an immediate threat to his life (ventricular arrhythmia, neoplasia, not fully cured or treated in the last three months), labile diabetes mellitus would represent a restriction on the participation or satisfactory completion of the study, or it would constitute an additional risk for the patient when administering the study drug. • The patient has significant or unexplained abnormalities in the laboratory measurements of Visit 2 (Appendices 1 and 2). • The patient is at least 40% above or below normal weight for his height and body build (based on the Height and Weight Tables of Metropolitan Life Insurance Co., Appendix 3). Medicines • The patient has taken the following antiasthmatic medication before Visit 1: o Oral, inhaled, intravenous, intramuscular or intraarticular corticosteroids within one month (prior use of steroids is allowed, if one month prior to the start of the study). or Cromolin, Nedocromil or Antagonists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary endpoint of efficacy will correspond to the percentage of days that meet the requirements of days without asthma during period II of the test. The secondary end points will be: (a) use of beta-agonist when necessary, (b) days with symptoms, (c) percentage of days without rescue medication for asthma, (d) quality of life specific to asthma , (e) VEFl / FEM, (f) asthma attacks, (g) nocturnal awakenings, (h) global evaluation of the patient on asthma, (i) blood eosinophil count and (j) safety and tolerability in adult asthmatic patients . Measure:Efficacy Timepoints:Mainly on visits 3, 4, 5, 6, and 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be recorded in the Adverse Event Case Report Forms. Measure:Safety Timepoints:During the whole study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed