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The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)
This study is ongoing, but not recruiting participants.
Study NCT00156819   Information provided by American Lung Association Asthma Clinical Research Centers
First Received: September 8, 2005   No Changes Posted

September 8, 2005
September 8, 2005
June 2003
 
Asthma treatment failure
Same as current
No Changes Posted
  • Pulmonary function
  • Symptoms
  • Medication use
  • Patient measures (questionnaires)
  • Markers of inflammation
Same as current
 
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)

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.

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).

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Asthma
  • Drug: fluticasone
  • Drug: montelukast
  • Drug: fluticasone/salmeterol combination
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
495
July 2005
 

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00156819
 
ALAACRC-03
American Lung Association Asthma Clinical Research Centers
GlaxoSmithKline
Study Chair: Nicholas Anthonisen, MD University of Winnipeg
American Lung Association Asthma Clinical Research Centers
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP