The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00156819

Recruitment Status : Completed

First Posted : September 12, 2005

Results First Posted : December 9, 2015

Last Update Posted : December 9, 2015

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

JHSPH Center for Clinical Trials

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Drug: fluticasone Drug: montelukast Drug: Fluticasone plus salmeterol	Phase 4

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).

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Study Start Date :	June 2003
Actual Primary Completion Date :	August 2005
Actual Study Completion Date :	August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Montelukast Fluticasone furoate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Fluticasone Participants continued fluticasone (100 microgram twice daily) treatment.	Drug: fluticasone fluticasone (100 microgram twice daily) treatment Drug: montelukast Montelukast (5 or 10 mg each night). Drug: Fluticasone plus salmeterol fluticasone (100 microgram) plus salmeterol (50 microgram) each night
Experimental: Montelukast Participants were changed to Montelukast (5 or 10 mg each night).	Drug: fluticasone fluticasone (100 microgram twice daily) treatment Drug: montelukast Montelukast (5 or 10 mg each night). Drug: Fluticasone plus salmeterol fluticasone (100 microgram) plus salmeterol (50 microgram) each night
Experimental: Fluticasone plus salmeterol Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.	Drug: fluticasone fluticasone (100 microgram twice daily) treatment Drug: montelukast Montelukast (5 or 10 mg each night). Drug: Fluticasone plus salmeterol fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Outcome Measures

Primary Outcome Measures :

Treatment Failure [ Time Frame: 16 weeks ]
The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	6 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

physician-diagnosed asthma
age 6 or older
pre-bronchodilator forced expiratory volume (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156819

Locations

Show 19 study locations

Layout table for location information

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

JHSPH Center for Clinical Trials

GlaxoSmithKline

Investigators

Layout table for investigator information

Study Chair:	Nicholas Anthonisen, MD	University of Winnipeg

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lang JE, Hossain J, Dixon AE, Shade D, Wise RA, Peters SP, Lima JJ; American Lung Association-Asthma Clinical Research Centers. Does age impact the obese asthma phenotype? Longitudinal asthma control, airway function, and airflow perception among mild persistent asthmatics. Chest. 2011 Dec;140(6):1524-1533. doi: 10.1378/chest.11-0675. Epub 2011 Jul 28.

Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.

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. Erratum in: N Engl J Med. 2007 Aug 16;357(7):728.

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00156819
Other Study ID Numbers:	ALAACRC-03
First Posted:	September 12, 2005 Key Record Dates
Results First Posted:	December 9, 2015
Last Update Posted:	December 9, 2015
Last Verified:	November 2015

Keywords provided by JHSPH Center for Clinical Trials:


Asthma Asthma Control

Additional relevant MeSH terms:

Layout table for MeSH terms

Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Xhance Salmeterol Xinafoate Montelukast Anti-Inflammatory Agents Bronchodilator Agents	Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Leukotriene Antagonists Hormone Antagonists

To Top