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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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

DOUBLE

Participants Investigators

Study Groups

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Montelukast 0.1 mg

Participants receive Montelukast inhalation powder, 0.1 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

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

Montelukast 0.3 mg

Participants receive Montelukast inhalation powder, 0.3 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

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

Montelukast 1 mg

Participants receive Montelukast inhalation powder, 1 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

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

Montelukast 3 mg

Participants receive Montelukast inhalation powder, 3 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

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

Montelukast 10 mg

Participants receive Montelukast inhalation powder, 10 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

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

Placebo

Participants receive Placebo to Montelukast inhalation powder.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo dry powder inhaler

Interventions

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Montelukast

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

Intervention Type DRUG

Placebo

Placebo dry powder inhaler

Intervention Type DRUG

Other Intervention Names

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Montelukast Sodium MK-0476

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No