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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: aminophylline hydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442338

0476-334

MK-0476-334

2007_007

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Montelukast 7 mg

Experimental group

Description:

Montelukast 7 mg IV administration

Treatment:

Drug: montelukast sodium

Drug: montelukast sodium

Montelukast 14 mg

Experimental group

Description:

Montelukast 14 mg IV administration

Treatment:

Drug: montelukast sodium

Drug: montelukast sodium

Aminophylline 250 mg

Active Comparator group

Description:

Aminophylline 250 mg IV drip administration

Treatment:

Drug: aminophylline hydrate