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

Asthma Clinical Trial

Official title:

MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442338
• Other study ID #: 0476-334
• Secondary ID: MK-0476-3342007_
• Status: Completed
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
• montelukast sodium
Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
• aminophylline hydrate
Aminophylline 250 mg IV drip infusion over 60 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration	The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.	Baseline and 60 minutes after study drug administration