Long-acting Beta Agonist Step Down Study

Condition(s) targeted: Asthma

Intervention: Fluticasone/Salmeterol Diskus (Drug); Fluticasone/Salmeterol Diskus (Drug); Fluticasone Diskus (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Robert A Wise, MD, Study Director, Affiliation: Johns Hopkins University
Linda Rogers, MD, Principal Investigator, Affiliation: New York University School of Medicine

Overall contact:
Joy Saams, RN, Phone: 410-502-9145, Email: jsaams@jhsph.edu

This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.

Official title: Long-acting Beta Agonist Step Down Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Treatment Failure

Secondary outcome:

Pulmonary Function

Rate of episodes of poor asthma control

Detailed description: Current asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. For patients treated with inhaled corticosteroids (ICS) alone, a dose reduction of 25-50% to a minimal dose that controls disease is recommended. The optimal approach to reducing treatment in patients with asthma treated with combination inhaled corticosteroids and long-acting beta agonists (ICS/LABA) is not clear. The American Lung Association Asthma Clinical Research Center (ALAACRC) is a network of 18 asthma research centers with the goal of performing clinical trials directly relevant to clinical practice. The question of the optimal way to de-escalate therapy in patients with asthma that is well controlled on fixed dose combination ICS/LABA is a key question for practitioners caring for patients with moderate to severe persistent asthma. We propose a 56 week multi-center, prospective, randomized, three-arm parallel group comparative effectiveness study comparing three approaches to care of patients with asthma well-controlled for three months on combination ICS/LABA: reduction of ICS dose and maintenance of LABA, initial discontinuation of LABA with continuation of ICS, and continuation of stable dose ICS/LABA. Our primary goal is to perform a pragmatic study that resembles clinical practice and determine the optimal treatment strategy that results in the lowest rate of treatment failure over 48 weeks of follow-up. Additional exploratory analyses include assessing risk factors for step-down failure, and to assess the duration of time that asthma control is maintained when therapy is de-escalated.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age 12-80 years

- physician diagnosed asthma that is well-controlled on moderate dose ICS/LABA

based on an Asthma Control Test (ACT) score more than or equal to 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment

- pre-bronchodilator FEV1 more than or equal to 70% predicted

Exclusion Criteria:

- chronic oral steroid therapy

- hospitalization or urgent care visit within 4 weeks of the screening visit

- lung disease other than asthma including COPD, bronchiectasis, sarcoidosis or other

lung disease

- less than 10 pack/yr of tobacco use and abstinence for at least 1 yr

- history of extensive environmental tobacco exposure or occupational exposure

suggestive of possible COPD per judgment of investigator

- post bronchodilator FEV1 less than 70% predicted

- near fatal asthma (intubation or ICU admission for asthma) within 2 yrs of enrollment

- high risk of near fatal or fatal asthma

- history of known premature birth less than 33 weeks or any significant level of

respiratory care including prolonged oxygen administration or mechanical ventilation during the neonatal period

- unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial

fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension)

- other major chronic illnesses which in the judgment of the study physician would

interfere with participation in the study e. g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder

- drug allergies to any component of study drug or history of adverse reaction to short

or long acting beta agonists

- for women of child bearing potential; not pregnant, not lactating and agree to

practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study

Joy Saams, RN, Phone: 410-502-9145, Email: jsaams@jhsph.edu

University of Arizona, Arizona Respiratory Center, Tucson, Arizona 85724, United States; Recruiting
Monica Vasquez, MPH, MED, Phone: 520-626-3907, Email: mvasquez@arc.arizona.edu
Lynn Gerald, PhD, MSPH, Principal Investigator

University of Southern California, San Diego, San Diego, California 92103, United States; Recruiting
Tonya Greene, Phone: 619-471-0823, Email: tgreene@ucsd.edu
Samang Ung, Phone: 619-471-0819
Joe Ramsdell, MD, Principal Investigator

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Nancy Archer, RN, Phone: 904-697-3465, Email: narcher@nemours.org
John Lima, PharmD, Principal Investigator

University of Missouri, Kansas City School of Medicine, Kansas City, Missouri 64108, United States; Recruiting
Patti Haney, RN. CCRP, Phone: 816-404-5503, Email: Patti.Haney@tmcmed.org
Gary Salzman, MD, Principal Investigator

Washington University/St. Louis University, St. Louis, Missouri 63110, United States; Recruiting
Jaime J Tarsi, RN, MPH, Phone: 314-747-3074, Email: jtarsi@dom.wustl.edu
Mario Castro, MD, MPH, Principal Investigator

Hofstra North Shore-LIJ School of Medicine, New Hyde Park, New York 11040, United States; Recruiting
Ramona Ramdeo, MSN, FNP-C, RN, RT, Phone: 516-465-5461, Email: rramdeo@lij.edu
Rubin Cohen, MD, Principal Investigator

New York University School of Medicine, New York, New York 10016, United States; Recruiting
Karen Carapetyan, MA, Phone: 212-263-2252, Email: carapk01@nyumc.org
Linda Rogers, MD, Principal Investigator

Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College, Valhalla, New York 10595, United States; Recruiting
Ingrid Gherson, MPH, Phone: 914-594-3320, Email: INGRID_GHERSON@NYMC.edu
Lisa Monchil, Phone: 914 594-3317
Alan Dozor, MD, Principal Investigator

University of Virginia, Charlottesville, Virginia 22908, United States; Recruiting
Donna Wolfe, PhD, Phone: 434-982-4086, Email: dlw9t@virginia.edu
William G Teague, Principal Investigator

American Lung Association

Starting date: March 2012
Last updated: July 2, 2012