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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for phase_4 asthma

Timeline

Completed

Started Jun 2003

Longer than P75 for phase_4 asthma

Geographic Reach

1 country

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

June 1, 2003

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed

9.4 years until next milestone

Results Posted

Study results publicly available

December 9, 2015

Completed

Last Updated

December 9, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

September 8, 2005

Results QC Date

November 4, 2015

Last Update Submit

November 4, 2015

Conditions

Asthma

Keywords

AsthmaAsthma Control

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

Fluticasone

ACTIVE COMPARATOR

Participants continued fluticasone (100 microgram twice daily) treatment.

Drug: fluticasoneDrug: montelukastDrug: Fluticasone plus salmeterol

Montelukast

EXPERIMENTAL

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

Drug: fluticasoneDrug: montelukastDrug: Fluticasone plus salmeterol

Fluticasone plus salmeterol

EXPERIMENTAL

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

Drug: fluticasoneDrug: montelukastDrug: Fluticasone plus salmeterol

Interventions

fluticasoneDRUG

fluticasone (100 microgram twice daily) treatment

FluticasoneFluticasone plus salmeterolMontelukast

montelukastDRUG

Montelukast (5 or 10 mg each night).

FluticasoneFluticasone plus salmeterolMontelukast

Fluticasone plus salmeterolDRUG

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

FluticasoneFluticasone plus salmeterolMontelukast

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

current or past smoking (greater than 20 pack-years)
chronic or current oral steroid therapy
pregnancy, lack of effective contraception (when appropriate), lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

JHSPH Center for Clinical Trialslead
GlaxoSmithKlinecollaborator

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

National Jewish Hospital

Denver, Colorado, 80206, United States

Location

Nemour's Childrens Center

Jacksonville, Florida, 32207, United States

Location

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

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Missouri at Kansas City

Kansas City, Missouri, 64108, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Long Island Jewish Hospital (and North Shore Hospital)

New Hyde Park, New York, 11040, United States

Location

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

New York, New York, 10016, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

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

Burlington, Vermont, 05405, United States

Location

Related Publications (5)

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.
PMID: 39497092DERIVED
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.
PMID: 37461659DERIVED
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.
PMID: 21799027DERIVED
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.
PMID: 20851928DERIVED
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.
PMID: 17507702DERIVED

MeSH Terms

Conditions

Asthma

Interventions

FluticasonemontelukastSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Results Point of Contact

Title: Razan Yasin
Organization: Johns Hopkins Center for Clinical Trials

Study Officials

Nicholas Anthonisen, MD
University of Winnipeg
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2006

Last Updated

December 9, 2015

Results First Posted

December 9, 2015

Record last verified: 2015-11

Locations

US(19)

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Fluticasone

Montelukast

Fluticasone plus salmeterol

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Fluticasone

Montelukast

Fluticasone plus salmeterol

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations