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) - Full Text View

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Montelukast Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476

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:

Number of Participants Who Experienced At Least One Adverse Event [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]
Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 7 days after last dose of study drug ] [ Designated as safety issue: Yes ]
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
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.
AUC 0-24hr of Montelukast - Multiple Doses [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Cmax of Montelukast - Multiple Doses [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time to Cmax (Tmax) of Montelukast - Single Dose [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Tmax of Montelukast - Multiple Doses [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
t1/2 of Montelukast - Multiple Doses [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: No ]
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses [ Time Frame: up to 10 days after first dose of study drug ] [ Designated as safety issue: No ]
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Cmax Accumulation Ratio of Montelukast - Multiple Doses [ Time Frame: up to 10 days after first dose of study drug ] [ Designated as safety issue: No ]
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.

Enrollment:	46
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
Experimental: 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.	Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names: Montelukast Sodium MK-0476
Experimental: 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.	Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names: Montelukast Sodium MK-0476
Experimental: 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.	Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names: Montelukast Sodium MK-0476
Experimental: 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.	Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names: Montelukast Sodium MK-0476
Experimental: 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.	Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names: Montelukast Sodium MK-0476
Placebo Comparator: 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.	Drug: Placebo Placebo dry powder inhaler

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 (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

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

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00636207 History of Changes
Other Study ID Numbers:	MK-0476-380, 2008_516
Study First Received:	March 3, 2008
Results First Received:	December 20, 2012
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013