A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

Organon and Co46 enrolled

Overview

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

MontelukastDRUG

Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg

PlaceboDRUG

Placebo dry powder inhaler

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female between the ages of 18 and 65 * Must have mild or moderate asthma (Part III only) * Nonsmoker for at least 6 months Exclusion Criteria: * History of stroke, chronic seizures or major neurological disorder * You are nursing * Drink more than 3 glasses of alcohol a day * Have allergy to or not able to tolerate lactose * Have a history of drug abuse in the last 5 years * Drink more than 6 beverages containing caffeine a day * Have had surgery, donated blood or participated in another investigational study in the last 4 weeks

Outcomes

Primary Outcomes

Number of Participants Who Experienced At Least One Adverse Event

Time frame: Up to 14 days after last dose of study drug

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame: Up to 7 days after last dose of study drug

Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose

Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.