Intermittent and Daily Dosing for Episodic (Periodic) Asthma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00337675

Purpose

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: Placebo (unspecified)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

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 asthma episodes culminating in asthma attack over the 1-year treatment period [ Time Frame: 1-year treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Daily average of wheeze and difficulty breathing in the 3 days prior to start of an asthma attack within an asthma episode [ Time Frame: 1-year treatment period ] [ Designated as safety issue: No ]
Daily average of the mean symptom scores (wheeze, difficulty breathing, interference with activity, and daytime cough) assessed over the 12-day treatment period of asthma episodes [ Time Frame: 1-year treatment period ] [ Designated as safety issue: No ]

Enrollment:	1771
Study Start Date:	October 2006
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: drug + episodic supplemental placebo: Active Comparator Montelukast qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period	Drug: montelukast sodium Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Arm 2: placebo comparator + episodic supplemental drug: Active Comparator Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period	Drug: montelukast sodium Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Arm 3: placebo comparator + episodic supplemental placebo: Placebo Comparator Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period	Drug: Comparator: Placebo (unspecified) Pbo qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 6 months to 5 years with episodic (periodic) asthma

Exclusion Criteria:

Patients who are not in otherwise good health
Patients who have persistent asthma (continual asthma symptoms)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337675

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:	2006_015, MK0476-302
Study First Received:	June 14, 2006
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00337675 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