Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-08-31

Brief Summary

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The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Montelukast 7 mg

Montelukast 7 mg IV administration

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes

Montelukast 14 mg

Montelukast 14 mg IV administration

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

Montelukast 14 mg single injection (IV bolus administration) over 5 minutes

Aminophylline 250 mg

Aminophylline 250 mg IV drip administration

Group Type ACTIVE_COMPARATOR

aminophylline hydrate

Intervention Type DRUG

Aminophylline 250 mg IV drip infusion over 60 minutes

Interventions

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montelukast sodium

Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes

Intervention Type DRUG

montelukast sodium

Montelukast 14 mg single injection (IV bolus administration) over 5 minutes

Intervention Type DRUG

aminophylline hydrate

Aminophylline 250 mg IV drip infusion over 60 minutes

Intervention Type DRUG

Other Intervention Names

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MK-0476 MK-0476 Kyophyllin® Injection 2.5%, FK05

Eligibility Criteria

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Inclusion Criteria

* Adult participants with acute asthma attacks

Exclusion Criteria

* Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
* Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
* Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No