Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier:
NCT00156819
First received: September 8, 2005
Last updated: November 4, 2015
Last verified: November 2015
  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 plus salmeterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Resource links provided by NLM:


Further study details as provided by JHSPH Center for Clinical Trials:

Primary Outcome Measures:
  • Treatment Failure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 500
Study Start Date: June 2003
Study Completion Date: August 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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
JHSPH Center for Clinical Trials
GlaxoSmithKline
Investigators
Study Chair: Nicholas Anthonisen, MD University of Winnipeg
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00156819     History of Changes
Other Study ID Numbers: ALAACRC-03 
Study First Received: September 8, 2005
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by JHSPH Center for Clinical Trials:
Asthma
Asthma Control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016