The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

JHSPH Center for Clinical Trials

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Fluticasone plus salmeterol; Drug: montelukast; Drug: fluticasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00156819

ALAACRC-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 3 patient groups

Fluticasone

Active Comparator group

Description:

Participants continued fluticasone (100 microgram twice daily) treatment.

Treatment:

Drug: montelukast

Drug: Fluticasone plus salmeterol

Drug: fluticasone

Montelukast

Experimental group

Description:

Participants were changed to Montelukast (5 or 10 mg each night).

Treatment:

Drug: montelukast

Drug: Fluticasone plus salmeterol

Drug: fluticasone

Fluticasone plus salmeterol

Experimental group

Description:

Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.

Treatment:

Drug: montelukast

Drug: Fluticasone plus salmeterol

Drug: fluticasone