The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial) - Full Text View

Purpose

This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Condition	Intervention	Phase
Asthma	Drug: fluticasone Drug: montelukast Drug: fluticasone/salmeterol combination	Phase IV

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Corticosteroids Fluticasone propionate Fluticasone Montelukast sodium Montelukast Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)

Further study details as provided by American Lung Association Asthma Clinical Research Centers:

Primary Outcome Measures:

Asthma treatment failure

Secondary Outcome Measures:

Pulmonary function
Symptoms
Medication use
Patient measures (questionnaires)
Markers of inflammation

Estimated Enrollment:	495
Study Start Date:	June 2003
Estimated Study Completion Date:	July 2005

Detailed Description:

This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

physician-diagnosed asthma
age 6 or older
pre-bronchodilator FEV1 of at least 60% of predicted
beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
Juniper Asthma Control Score of 1.5 or greater if not on daily controller
good current health

Exclusion Criteria:

current or past smoking (greater than 20 pack-years)
chronic or current oral steroid therapy
pregnancy, lack of effective contraception (when appropriate), lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156819

Locations


United States, Alabama
	University of Alabama at Birmingham
	Birmingham, Alabama, United States, 35233

United States, Colorado
	National Jewish Hospital
	Denver, Colorado, United States, 80206

United States, Florida
	Nemour's Childrens Center
	Jacksonville, Florida, United States, 32207
	University of Miami (and University of South Florida in Tampa)
	Miami, Florida, United States, 33136

United States, Georgia
	Emory University
	Atlanta, Georgia, United States, 30322

United States, Illinois
	Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
	Chicago, Illinois, United States, 60611

United States, Indiana
	Indiana University
	Indianapolis, Indiana, United States, 46202

United States, Louisiana
	Louisiana State University
	New Orleans, Louisiana, United States, 70112

United States, Minnesota
	University of Minnesota
	Minneapolis, Minnesota, United States, 55455

United States, Missouri
	University of Missouri at Kansas City
	Kansas City, Missouri, United States, 64108
	Washington University
	St. Louis, Missouri, United States, 63110

United States, New York
	Long Island Jewish Hospital (and North Shore Hospital)
	New Hyde Park, New York, United States, 11040
	New York Consortium (New York Univ. and Columbia Univ.)
	New York, New York, United States, 10016
	New York Medical College
	Valhalla, New York, United States, 10595

United States, North Carolina
	Duke University School of Medicine
	Durham, North Carolina, United States, 27710

United States, Ohio
	Ohio State University
	Columbus, Ohio, United States, 43210

United States, Pennsylvania
	Thomas Jefferson Hospital
	Philadelphia, Pennsylvania, United States, 19107

United States, Texas
	Baylor College of Medicine
	Houston, Texas, United States, 77030

United States, Vermont
	Northern New England Consortium (Univ. of Vermont and other locations)
	Burlington, Vermont, United States, 05405

Sponsors and Collaborators

American Lung Association Asthma Clinical Research Centers

GlaxoSmithKline

Investigators


Study Chair:	Nicholas Anthonisen, MD	University of Winnipeg

More Information

American Lung Association Asthma Clinical Research Centers This link exits the ClinicalTrials.gov site

Publications indexed to this study:

American Lung Association Asthma Clinical Research Centers; Peters SP, Anthonisen N, Castro M, Holbrook JT, Irvin CG, Smith LJ, Wise RA. Randomized comparison of strategies for reducing treatment in mild persistent asthma. N Engl J Med. 2007 May 17;356(20):2027-39.

Study ID Numbers:	ALAACRC-03
First Received:	September 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00156819
Health Authority:	United States: Food and Drug Administration

Keywords provided by American Lung Association Asthma Clinical Research Centers:

Asthma

Asthma Control

Study placed in the following topic categories:

Montelukast

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Leukotriene Antagonists

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Anti-Allergic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	American Lung Association Asthma Clinical Research Centers GlaxoSmithKline
Information provided by:	American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:	NCT00156819