None listed
Conditions
Interventions
Montelukast +Futicasona Type of group
Group 1 will receive active montelukast (10 mg, blinded) added to active fluticasone (200 ug daily, open-label) and placebo salmeterol (blinded) inhaler
Group name:Salmeterol+ Fluticasona Type of group
Group 2 will receive active fluticasone (200 ug daily, open-label) with addition of 50 ug (two puffs) twice daily active salmeterol inhaler (blinded) and placebo montelukast tablets (blinded).
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Patient understands the study procedures and agrees to participate by signing the appropriate informed consent form. b. Patient is a male or female and at least 15 and not more than 65 years of age at Visit 1. Female patients of childbearing potential must demónstrate a b-hCG level consistent with a non-gravid State at randomization and agree to use appropriate contraceptives (oral or single barrier); beginning at least 7 days before Visit 1 and continuing at least 14 days after Visit 9 or discontinuation visit. c. Patient has been a regular user of inhaled corticosteroids at dosages for at least eight weeks before Visit 1 (Prestudy Visit). d. Patient fulfills all the following signs and symptoms of asthma by Visit 3: 1) A consistent clinical history, at least one year in duration, of intermittent or persistent symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production. 2) A forced expiratory volume in one second (FEVi), while withholding P-agonist for at least six hours, of between 50% and 90% (inclusive) of the predicted valué on at least two occasions at Visits 1, 2 or 3. 3) Evidence of reversible airway obstruction, as defíned by an increase in FEVi or peak expiratory flow rate of >12% (absolute value) of predicted, 20 to 30 minutes after inhaled p -agonist administration on at least one occasion at Visits 1, 2, 3 or within the previous 12 months. 4) A predetermined level of daytime symptoms (bi-weekly score of at least 56) and beta-agonist use (average of at least one puff/day) as recorded during the two weeks between Visits 2 and 3. e. Patient´s present asthma treatment Includes only short-acting inhaled beta-agonists and inhaled corticosteroids at the prestudy visit. f. Patient is currently a nonsmoker and has been a nonsmoker for at least six months prior to Visit 1, with a smoking history of no more than twelve pack-years [i.e., one pack (20 cigarettes) per day for twelve years]. g. Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data and appears able to successfully complete this trial.
Exclusion criteria
Exclusion criteria: General a. Patient is under the age of legal consent and consent cannot be obtained from parent or guardián. b. Patient is, in the opinión of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. c. Patient is hospitalized. d. Patient is a female who is 160/95). p. Patient has a history of any illness that would require treatment with an excluded medication, could be immediately Ufe threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months), ´brittle´ diabetes mellitus would pose restriction on participation or successful compietion of the study, or would pose an additional risk to the patient by administering the study drug. q. Patient has significant and unexplained abnormalities on Period I laboratory measurements. r. Patient is at least 40% over or under normal weight for height and body build (based upen the Metropolitan Life Insurance Co., Height and Weight Tables). Medications s. Patient has taken the following anti-asthma medication before Visit 1: 1) Oral, intravenous, intramuscular, cutaneous or intra-articular corticosteroids within one month 2) Cromolyn, nedocromil or leukotriene receptor antagonists within two weeks 3) TheophyIIine within one week 4) Oral or long acting inhaled beta-agonists or inhaled anticholinergic agents within two weeks 5) Terfenadine, fexofenadine, loratadine or cetirizine within one week (astemizole within 3 months). t. Patient has taken any medication specifically excluded within 14 days of Vi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Percent of patients with at least one asthma attack during period II of the trial. Timepoints:For 48 weeks (Period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Patient and physician global assessment of asthma Timepoints:Visit 9 or upon discontinuation | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed