The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Asthma Clinical Trial

Official title:

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156819
• Other study ID #: ALAACRC-03
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: November 4, 2015
• Start date: June 2003
• Est. completion date: August 2006

Study information

• Verified date: November 2015
• Source: JHSPH Center for Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2006
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone
fluticasone (100 microgram twice daily) treatment
• montelukast
Montelukast (5 or 10 mg each night).
• Fluticasone plus salmeterol
fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northern New England Consortium (Univ. of Vermont and other locations)	Burlington	Vermont
United States	Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	National Jewish Hospital	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Nemour's Childrens Center	Jacksonville	Florida
United States	University of Missouri at Kansas City	Kansas City	Missouri
United States	University of Miami (and University of South Florida in Tampa)	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Long Island Jewish Hospital (and North Shore Hospital)	New Hyde Park	New York
United States	Louisiana State University	New Orleans	Louisiana
United States	New York Consortium (New York Univ. and Columbia Univ.)	New York	New York
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania
United States	Washington University	St. Louis	Missouri
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
JHSPH Center for Clinical Trials	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure	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.	16 weeks	No

External Links

•   American Lung Association Asthma Clinical Research Centers