A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE CLINICAL EFFECTS OF MONTELUKAST INTRAVENOUS WITH PLACEBO IN PEDIATRIC PATIENTS (BETWEEN 6 AND 14 YEARS OLD) WHO SUFFER FROM ACUTE ASTHMA

Not Applicable

• Conditions: -J459 Asthma, unspecified; Asthma, unspecified; J459

• Registration Number: PER-028-05
• Lead Sponsor: MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) The patient is a man or a woman from 6 to 14 years of age.
b) The patient who has begun to menstruate has a pregnancy test in serum or urine with negative results before randomization.
c) The patient presents at the study site for the treatment of symptoms that coincide with an asthma exacerbation.
d) The patient has a history of symptoms similar to asthma on at least 1 occasion, which occurs at least within 3 months prior to the current episode.
e) During Period I, the patient has an mPI score of> 6 in both measurements.
f) The patient has a FEV1 g) The parent / caregiver and the patient accept the patient s participation in the study.
h) The patient is within the 3rd and 97th percentile of height range and weight-for-age range.

Exclusion Criteria

a) The patient has some known or suspected cause, acute or chronic, for his pulmonary symptoms other than asthma.
b) The asthma that the patient suffers has characteristics that threaten life.
c) The time between the start of standard treatment for acute asthma at the study site and the administration of the study drug exceeds 120 minutes.
d) The patient has a comorbid disorder other than asthma.
e) The patient has received an oral leukotriene receptor antagonist or an inhibitor of leukotriene synthesis within 24 hours prior to randomization.
f) The patient has received some anti-asthma therapies other than oxygen, B-agonists, anticholinergics or corticosteroids between the presentation in the ED and the randomization.
g) The patient has an active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, psychiatric, renal, genitourinary or hematological systems.

Study & Design

• Study Type: Interventional
• Study Design: Not specified