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

NCT00442338 | Completed Phase 3 Results

• 3 other identifiers: 0476-334MK-0476-3342007_007
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Montelukast 7 mg

EXPERIMENTAL

Montelukast 7 mg IV administration

Drug: montelukast sodium

Montelukast 14 mg

EXPERIMENTAL

Montelukast 14 mg IV administration

Drug: montelukast sodium

Aminophylline 250 mg

ACTIVE COMPARATOR

Aminophylline 250 mg IV drip administration

Drug: aminophylline hydrate

Interventions

montelukast sodium DRUG

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

Also known as: MK-0476

Montelukast 7 mg

aminophylline hydrate DRUG

Aminophylline 250 mg IV drip infusion over 60 minutes

Also known as: Kyophyllin® Injection 2.5%, FK05

Aminophylline 250 mg

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants with acute asthma attacks

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Theophylline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 2, 2022
• Results First Posted: July 14, 2009

Record last verified: 2022-01