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Completed

NCT Number: NCT00156819

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone

Drug

fluticasone (100 microgram twice daily) treatment

Montelukast

Drug

Montelukast (5 or 10 mg each night).

Fluticasone plus salmeterol

Drug

fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Primary outcomes

  1. Treatment Failure

    Time frame: 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

JHSPH Center for Clinical Trials

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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