None listed
Conditions
Interventions
Montelukast 7 - Montelukast Type of group
Period I: Montelukast 7mg IV for 6 hours
Period II Montelukast 10 mg VO for 28 days
Group name:Placebo - Placebo Type of group
Period I: Placebo IV for 6 hours
Period II: Placebo tablet for 28 days
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient is male or female and at least 15 years old. Patients over 54 years of age can enter as long as they comply with BOTH of the following: (1) a diagnosis of asthma by a doctor for more than one year and (2) reversibility of documented FEV1 (improvement of> 15% above the baseline) after treatment with agonist B, in the last year. • Note: All female patients of reproductive age must show a level of 6-hCG consistent with a non-gravid state prior to randomization. For inclusion in the outpatient extension, patients must agree to use appropriate contraceptives • Patient is admitted to the study site due to an acute asthma exacerbation and has a history of at least 1 year (may be verbal of the patient) of asthma. Note: patients over 54 years of age must meet the additional history criteria mentioned above. • During Period I, patient has a forced expiratory volume in one second (FEV1) of <70% of the predicted value in each measurement. • The patient has a smoking history of no more than 15 packages per year [eg; one pack (20 cigars) per day for 15 years]. • Patient understands the study procedures and agrees to participate by signing the appropriate informed consent.
Exclusion criteria
Exclusion criteria: • Based on history or physical examination at the study site, the patient has any acute or chronic, recognized or suspected cause of his pulmonary symptoms outside of asthma (eg, congestive heart failure, etc.) • When assessed by the study site, patient asthma has life-threatening characteristics including, but not limited to, evidence of a pneumothorax or pneumomediastinum, • When evaluated by the study site, the patient has a fever (temperature> 38.3 ° C) OR has signs or symptoms of pneumonia due to history, physical examination, laboratory evaluation or chest x-ray. • The time between the patient´s admission to the study site and the study drug administration exceeds 75 minutes. • The percentage of predicted FEVi value has increased or decreased by> 20 percentage points between any 2 measurements during Period I (before the drug administration). • Patient has any other comorbid disorder outside of asthma diagnosed by history, physical examination, or laboratory results (Appendix 1) that would require therapy during Period II. • Patient has received any dose of coiticosteroids greater than its usual dose within 12 hours of admission to the study site. Up to 20% of randomized patients in each study site will be allowed to receive systemic corticosteroids (including a dose higher than their usual dose) during the 12 hours prior to entering the study site through the pre-assignment period (period I), if said therapy was considered necessary by the study site. Note: No more than 20% of patients randomized in the study will be allowed to receive either systemic and / or anti-leukotriene corticosteroids as described in Section LD.2.j below. • Patient has received any anti-asthmatic therapy out of oxygen or up to 2 nebulizations of agonists 6 during Period I (before being assigned). • Patient has clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, renal, genitourethral, ​​or hematologic systems, including but not limited to: severe cardiac disease, congestive heart failure, sickle cell disease, acquired immunodeficiency syndrome (AIDS), liver disease chronic or acute or terminal renal failure. • Patient has initiated an oral leukotriene receptor antagonist or a leukotriene synthesis inhibitor (on the market or research) within two weeks of entering the study site. Up to 20% of patients randomized to each study site can be with. Stable chronic doses of antileukotriene agents, provided that the last dose has not been taken within 12 hours before entering the study site. Note: No more than 20% of patients randomized in the study will be allowed to receive either systemic corticosteroids and / or anti-leukotrienes as described in Section I.D.2.g above. • Patient has a history of a disease that could be of immediate life threat (eg, ventricular arrhythmia, neoplasia, not fully cured or treated in the last 3 months, weak diabetes mellitus) and therefore have a high probability of prevent or otherwise interfere with the successful completion of the study. • Patient is unable or unwilling to comply with the study procedures, including the placement of an intravenous catheter OR that an intravenous catheter can not be placed due to technical problems. • Patient is, in the opinion of the investigator, legally or mentally incapacitated, preventing informed consent, or unable to read or understand written material, or comply with study or protocol proced
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Average FEV1 0 to 60 min. Measure:Percentage change in time calculated in FEV1 from baseline pre-enrollment through the first 60 minutes after study drug administration Timepoints:At 60 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Through spirometry and the average FEV1 at 10, 20, 40, 120 minutes and at discharge Measure:Percentage change in time calculated in FEV1 From the pre-enrollment baseline through the first 40, 20 and 10; and up to 120 minutes and until discharge Timepoints:at 10, 20, 40, 120 minutes and at discharge ; Outcome name:treatment failures defined as: (1) patients requiring hospitalization, (2) patients who continue to take therapy at the study site for more than 6 hours or (3) patients who require excluded therapy. Measure:Percentage of treatment failures Timepoints:When treatment ends ; Outcome name:Being assigned the current number of doses of agonist 6 that they received before they were declared treatment failures plus the number of doses presumed to be agonist 6 that they had received during the time interval Measure:The average number of doses of agonist 6 administered per patient in Period II with treatment failures Timepoints:6 hours ; Outcome name:Percentage of time from admission to study site to make a decision about whether to discharge or treatment failure Measure:Percentage of time from admission to study site to make a decision about whether to discharge or treatment failure Timepoints:Time to discharge ; Outcome name:Percentage of patients who received corticosteroids in Period II with treatment failures counted as receiving corticosteroids Measure:Percentage of patients who received corticosteroids in Period II with treatment failures counted as receiving corticosteroids Timepoints:After treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed