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Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)

NCT00200967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-01-23

Study results available
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Summary

The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Conditions

Interventions

DRUG

salmeterol

50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)

DRUG

beclomethasone HFA

240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Asthma Clinical Research Network

    collaborator NETWORK

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Homer Boushey · University of California, San Francisco

  • Mario Castro · Washington University School of Medicine

  • Vernon M. Chinchilli, PhD · Milton S. Hershey Medical Center

  • Elliot Israel · Brigham and Women's Hospital

  • Robert Lemanske · University of Wisconsin, Madison

  • Richard Martin · National Jewish Medical & Research Center

  • Stephen Peters · Wake Forest University Health Sciences

  • Stephen Wasserman · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00200967 on ClinicalTrials.gov