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The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

NCT ID: NCT00156819

Last Updated: 2015-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-08-31

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).

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluticasone

Participants continued fluticasone (100 microgram twice daily) treatment.

Group Type ACTIVE_COMPARATOR

fluticasone

Intervention Type DRUG

fluticasone (100 microgram twice daily) treatment

montelukast

Intervention Type DRUG

Montelukast (5 or 10 mg each night).

Fluticasone plus salmeterol

Intervention Type DRUG

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

Montelukast

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

Group Type EXPERIMENTAL

fluticasone

Intervention Type DRUG

fluticasone (100 microgram twice daily) treatment

montelukast

Intervention Type DRUG

Montelukast (5 or 10 mg each night).

Fluticasone plus salmeterol

Intervention Type DRUG

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

Fluticasone plus salmeterol

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

Group Type EXPERIMENTAL

fluticasone

Intervention Type DRUG

fluticasone (100 microgram twice daily) treatment

montelukast

Intervention Type DRUG

Montelukast (5 or 10 mg each night).

Fluticasone plus salmeterol

Intervention Type DRUG

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

Interventions

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fluticasone

fluticasone (100 microgram twice daily) treatment

Intervention Type DRUG

montelukast

Montelukast (5 or 10 mg each night).

Intervention Type DRUG

Fluticasone plus salmeterol

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

Intervention Type DRUG

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

JHSPH Center for Clinical Trials

OTHER

Sponsor Role lead

Principal Investigators

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Nicholas Anthonisen, MD

Role: STUDY_CHAIR

University of Winnipeg

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

National Jewish Hospital

Denver, Colorado, United States

Site Status

Nemour's Childrens Center

Jacksonville, Florida, United States

Site Status

University of Miami (and University of South Florida in Tampa)

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Louisiana State University

New Orleans, Louisiana, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Missouri at Kansas City

Kansas City, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Long Island Jewish Hospital (and North Shore Hospital)

New Hyde Park, New York, United States

Site Status

New York Consortium (New York Univ. and Columbia Univ.)

New York, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Duke University School of Medicine

Durham, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Northern New England Consortium (Univ. of Vermont and other locations)

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating microRNAs associated with bronchodilator response in childhood asthma. BMC Pulm Med. 2024 Nov 4;24(1):553. doi: 10.1186/s12890-024-03372-4.

Reference Type DERIVED
PMID: 39497092 (View on PubMed)

Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating MicroRNAs associated with Bronchodilator Response in Childhood Asthma. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-3101724. doi: 10.21203/rs.3.rs-3101724/v1.

Reference Type DERIVED
PMID: 37461659 (View on PubMed)

Lang JE, Hossain J, Dixon AE, Shade D, Wise RA, Peters SP, Lima JJ; American Lung Association-Asthma Clinical Research Centers. Does age impact the obese asthma phenotype? Longitudinal asthma control, airway function, and airflow perception among mild persistent asthmatics. Chest. 2011 Dec;140(6):1524-1533. doi: 10.1378/chest.11-0675. Epub 2011 Jul 28.

Reference Type DERIVED
PMID: 21799027 (View on PubMed)

Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.

Reference Type DERIVED
PMID: 20851928 (View on PubMed)

American Lung Association Asthma Clinical Research Centers; Peters SP, Anthonisen N, Castro M, Holbrook JT, Irvin CG, Smith LJ, Wise RA. Randomized comparison of strategies for reducing treatment in mild persistent asthma. N Engl J Med. 2007 May 17;356(20):2027-39. doi: 10.1056/NEJMoa070013.

Reference Type DERIVED
PMID: 17507702 (View on PubMed)

Related Links

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http://www.cctrials.org/alaacrc

American Lung Association Asthma Clinical Research Centers

Other Identifiers

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ALAACRC-03

Identifier Type: -

Identifier Source: org_study_id