Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

NCT00495157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2013-04-11

Study results available
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Summary

Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.

Conditions

Interventions

BEHAVIORAL

Symptom-based adjustment

Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

BEHAVIORAL

Biomarker-based adjustment

Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

BEHAVIORAL

Guideline-based adjustment

Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Sponsors & Collaborators

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

    collaborator NIH
  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • William J. Calhoun, MD · University of Texas, Galveston

  • Mario Castro, MD · Washington University School of Medicine

  • Robert F. Lemanske, MD · University of Wisconsin, Madison

  • Richard J. Martin, MD · National Jewish Health

  • Elliot Israel, MD · Brigham and Women's Hospital

  • Stephen P. Peters, MD, PhD · Wake Forest University Health Sciences

  • Homer A. Boushey, MD · University of California, San Francsico

  • Stephen I. Wasserman, MD · University of California, San Diego

  • Emily DiMango, MD · Columbia University

  • Monica Kraft, MD · Duke University

  • Reuben M. Cherniack, MD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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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 NCT00495157 on ClinicalTrials.gov