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The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00156819
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 9, 2015
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
JHSPH Center for Clinical Trials

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: fluticasone Drug: montelukast Drug: Fluticasone plus salmeterol Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Study Start Date : June 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2006


Arm Intervention/treatment
Active Comparator: Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
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

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

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156819


Locations
Show Show 19 study locations
Sponsors and Collaborators
JHSPH Center for Clinical Trials
GlaxoSmithKline
Investigators
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Study Chair: Nicholas Anthonisen, MD University of Winnipeg
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00156819    
Other Study ID Numbers: ALAACRC-03
First Posted: September 12, 2005    Key Record Dates
Results First Posted: December 9, 2015
Last Update Posted: December 9, 2015
Last Verified: November 2015
Keywords provided by JHSPH Center for Clinical Trials:
Asthma
Asthma Control
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Salmeterol Xinafoate
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists