Official Title: “A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild of Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK0476”

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled MK0476 in patients with mild or moderate asthma.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • Arm A: 3 mg capsules montelukast. Arm B: 10 mg capsules montelukast. 10 consecutive days of treatment.
• Drug: Comparator: placebo (unspecified)
  • Arm A: Pbo inhaled once daily. Arm B: Pbo inhaled once daily. 10 consecutive days of treatment.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • Arm A: 3 mg capsules montelukast/montelukast Pbo inhaled once daily.
• Placebo Comparator: B
  • Arm B: 10 mg capsules montelukast/montelukast Pbo inhaled once daily.

Primary Measures

• Evaluate the safety and tolerability of inhaled doses of MK0476.
  • Time Frame: 10 consecutive days of treatment
    Safety Issue?: Yes

Secondary Measures

• Evaluate the plasma pharmacokinetic data of inhaled doses of MK0476.
  • Time Frame: 10 consecutive days of treatment
    Safety Issue?: No

Inclusion Criteria:

• Male of female between the ages of 18 and 65
• Must have mild or moderate asthma
• 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 milk of 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636207

Study ID Number: 2008_516

ClinicalTrials.gov Identifier: NCT00636207

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site