NCT00156819

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-08-01
• Completion: 2006-08-01
• First posted: 2005-09-12
• Last updated: 2015-12-09
• Results posted: 2015-12-09

Locations

19 sites across 1 country: United States