The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Conditions
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Asthma

Intervention / Treatment
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* Drug: fluticasone
* Drug: montelukast
* Drug: Fluticasone plus salmeterol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluticasone<br>Participants continued fluticasone (100 microgram twice daily) treatment. | Drug: fluticasone<br>* fluticasone (100 microgram twice daily) treatment<br>Drug: montelukast<br>* Montelukast (5 or 10 mg each night).<br>Drug: Fluticasone plus salmeterol<br>* fluticasone (100 microgram) plus salmeterol (50 microgram) each night<br>|
| Experimental: Montelukast<br>Participants were changed to Montelukast (5 or 10 mg each night). | Drug: fluticasone<br>* fluticasone (100 microgram twice daily) treatment<br>Drug: montelukast<br>* Montelukast (5 or 10 mg each night).<br>Drug: Fluticasone plus salmeterol<br>* fluticasone (100 microgram) plus salmeterol (50 microgram) each night<br>|
| Experimental: Fluticasone plus salmeterol<br>Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. | Drug: fluticasone<br>* fluticasone (100 microgram twice daily) treatment<br>Drug: montelukast<br>* Montelukast (5 or 10 mg each night).<br>Drug: Fluticasone plus salmeterol<br>* fluticasone (100 microgram) plus salmeterol (50 microgram) each night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Asthma Control