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

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636207

0476-380

2008_516 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 6 patient groups, including a placebo group

Montelukast 0.1 mg

Experimental group

Description:

Participants receive Montelukast inhalation powder, 0.1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period.

Treatment:

Drug: Montelukast

Montelukast 0.3 mg

Experimental group

Description:

Participants receive Montelukast inhalation powder, 0.3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period.

Treatment:

Drug: Montelukast

Montelukast 1 mg

Experimental group

Description:

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.

Treatment:

Drug: Montelukast

Montelukast 3 mg

Experimental group

Description:

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.

Treatment:

Drug: Montelukast

Montelukast 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo