Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)

NCT ID: NCT00092989

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-03-31

Brief Summary

The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Montelukast 7 mg

Participants receive montelukast 7 mg intravenously (IV) until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

Duration of Treatment: 1 dose

Placebo

Participants receive placebo IV until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Duration of Treatment: 1 dose

Interventions

montelukast sodium

Duration of Treatment: 1 dose

Intervention Type: DRUG

placebo

Duration of Treatment: 1 dose

Intervention Type: DRUG

Other Intervention Names

MK-0476; montelukast

Eligibility Criteria

Inclusion Criteria

• Individuals with acute asthma

Exclusion Criteria

• Women of child bearing age
• History of Chronic Obstructive Pulmonary Disease (COPD)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Camargo CA Jr, Gurner DM, Smithline HA, Chapela R, Fabbri LM, Green SA, Malice MP, Legrand C, Dass SB, Knorr BA, Reiss TF. A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma. J Allergy Clin Immunol. 2010 Feb;125(2):374-80. doi: 10.1016/j.jaci.2009.11.015.

Reference Type: DERIVED

PMID: 20159247 (View on PubMed)

Other Identifiers

MK-0476-288

Identifier Type: OTHER

Identifier Source: secondary_id

2004_027

Identifier Type: OTHER

Identifier Source: secondary_id

0476-288

Identifier Type: -

Identifier Source: org_study_id