A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK0476 in Patients With Mild or Moderate Asthma. - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00636207

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Comparator: montelukast sodium Drug: Comparator: Placebo	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluate the safety and tolerability of inhaled doses of MK0476. [ Time Frame: 10 consecutive days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the plasma pharmacokinetic data of inhaled doses of MK0476. [ Time Frame: 10 consecutive days of treatment ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	August 2007
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 3 mg capsules montelukast/montelukast Pbo inhaled once daily.	Drug: Comparator: montelukast sodium Arm A: 3 mg capsules montelukast. Arm B: 10 mg capsules montelukast. 10 consecutive days of treatment. Drug: Comparator: Placebo Arm A: Pbo inhaled once daily. Arm B: Pbo inhaled once daily. 10 consecutive days of treatment.
B: Experimental 10 mg capsules montelukast/montelukast Pbo inhaled once daily.	Drug: Comparator: montelukast sodium Arm A: 3 mg capsules montelukast. Arm B: 10 mg capsules montelukast. 10 consecutive days of treatment. Drug: Comparator: Placebo Arm A: Pbo inhaled once daily. Arm B: Pbo inhaled once daily. 10 consecutive days of treatment.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636207

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_516, MK0476-380
Study First Received:	March 3, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00636207 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010