Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)

Summary

Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid (ICS) medication to control asthma symptoms. If a low dose of ICS is ineffective at controlling symptoms, the addition of a second controller medication is recommended. This study will examine the effectiveness of the medication tiotropium bromide combined with a low dose of ICS at maintaining asthma control in people with moderately severe asthma.

Conditions

• Asthma

Interventions

DRUG

tiotropium bromide

tiotropium bromide inhalation powder 18 mcg once daily

DRUG

salmeterol xinafoate

salmeterol xinafoate inhalation powder 50 mcg twice daily

DRUG

beclomethasone dipropionate

beclomethasone dipropionate 80 mcg twice daily (1xICS) or 160 mcg twice daily (2xICS)

Sponsors & Collaborators

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

  collaborator NIH

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

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

• Richard J. Martin, MD · National Jewish Health

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

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

• Mario Castro, MD · Washington University School of Medicine

• Emily A. DiMango, MD · Columbia University

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

• Monica Kraft, MD · Duke University

• William J. Calhoun, MD · University of Texas

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

• Reuben M. Cherniack, MD · National Jewish Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2010-05-31

Completion

2010-05-31

Countries

• United States

Study Locations