Long-acting Beta Agonist Step Down Study (LASST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Collaborators:
American Lung Association
GlaxoSmithKline
Information provided by (Responsible Party):
Robert A. Wise, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01437995
First received: September 5, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone/Salmeterol Diskus
Drug: Fluticasone Diskus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Long-acting Beta Agonist Step Down Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Treatment Failure [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.


Secondary Outcome Measures:
  • Pulmonary Function [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Pulmonary function measures: 1)morning peak expiratory flow rate (from the patients' daily diary cards) and 2)pre-BD FEV1 and bronchodilator response

  • Rate of episodes of poor asthma control [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning PEFR


Estimated Enrollment: 450
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone/Salmeterol Diskus 250/50 ug
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Drug: Fluticasone/Salmeterol Diskus
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Other Names:
  • Fluticasone
  • Salmeterol
Active Comparator: Fluticasone/Salmeterol Diskus 100/50 ug
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Drug: Fluticasone/Salmeterol Diskus
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Other Names:
  • Fluticasone
  • Salmeterol
Active Comparator: Fluticasone Diskus alone 250 ug
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Drug: Fluticasone Diskus
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Other Name: Fluticasone

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437995

Contacts
Contact: Joy Saams, RN 410-502-9145 jsaams@jhsph.edu

Locations
United States, Arizona
University of Arizona, Arizona Respiratory Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Monica Vasquez, MPH, MED    520-626-3907    mvasquez@arc.arizona.edu   
Principal Investigator: Lynn Gerald, PhD, MSPH         
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Katie Kinninger    619-471-0823    kkinninger@ucsd.edu   
Principal Investigator: Joe Ramsdell, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Trisha L Larson    303-270-1220    larsont@njhealth.org   
Principal Investigator: Rohit Katial         
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Archer, RN    904-697-3465    narcher@nemours.org   
Principal Investigator: John Lima, PharmD         
University of Miami/University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Ashley Addeo    813-631-4024 ext 207    aaddeo@health.usf.edu   
Principal Investigator: Adam Wanner, MD         
United States, Illinois
The Illinois Consortium Recruiting
Chicago, Illinois, United States, 60611
Contact: Jenny Hixon, BS, CCRC    312-926-0957    j-franzen@northwestern.edu   
Principal Investigator: Lewis J Smith, MD         
United States, Indiana
St. Vincent Hospital and Health Care Center, Inc Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Julie Martin, RN, MS    317-313-6323    jmarting015@stvincent.org   
Principal Investigator: Micheal F Busk, MD, MPH         
St. Vincent Healthcare Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Kimberly Sundblad    317-338-8032    KJSUNDBL@stvincent.org   
Principal Investigator: Michael Busk, MD         
United States, Louisiana
Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Marie Sandi, NP    504-568-3450    mchild@lsuhsc.edu   
Principal Investigator: Kyle I Happel, MD         
United States, Missouri
University of Missouri, Kansas City School of Medicine Recruiting
Kansas City, Missouri, United States, 64108
Contact: Patti Haney, RN. CCRP    816-404-5503    Patti.Haney@tmcmed.org   
Principal Investigator: Gary Salzman, MD         
Washington University/St. Louis University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jaime J Tarsi, RN, MPH    314-747-3074    jtarsi@dom.wustl.edu   
Principal Investigator: Mario Castro, MD, MPH         
United States, New York
Hofstra North Shore-LIJ School of Medicine Recruiting
New Hyde Park, New York, United States, 11040
Contact: Ramona Ramdeo, FNP-C, RN    516-465-5461    rramdeo@lij.edu   
Principal Investigator: Rubin Cohen, MD         
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Karen Carapetyan, MA    212-263-2252    carapk01@nyumc.org   
Principal Investigator: Linda Rogers, MD         
Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Ingrid Gherson, MPH    914-594-3320    INGRID_GHERSON@NYMC.edu   
Contact: Lisa Monchil    914 594-3317      
Principal Investigator: Alan Dozor, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Catherine Foss, RRT, CCRC    919-668-6530    catherine.foss@duke.edu   
Principal Investigator: John Sundy, MD, PhD         
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Janice Drake    614-366-2287    janice.drake@osumc.edu   
Contact: Joe Santiago, RRT    614-366-4593    joseph.santiago@osumc.edu   
Principal Investigator: John Mastronarde, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Laura Bertrand, RN, RPFT    713-798-2681    tyler@bcm.tmc.edu   
Principal Investigator: Nicola Hanania, MD, FCCP         
United States, Vermont
Northern New England Consortium Recruiting
Colchester, Vermont, United States, 05446
Contact: Stephanie M Burns    802-847-2103    stephanie.burns@vtmednet.org   
Principal Investigator: Charles Irvin, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kristin Wavell    434-982-4086    kww7d@virginia.edu   
Principal Investigator: William G Teague         
Sponsors and Collaborators
Johns Hopkins University
American Lung Association
GlaxoSmithKline
Investigators
Study Director: Robert A Wise, MD Johns Hopkins University
Principal Investigator: Linda Rogers, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Robert A. Wise, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01437995     History of Changes
Other Study ID Numbers: ADV115922
Study First Received: September 5, 2011
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Asthma
Step down therapy
Inhaled corticosteroids
Long-acting beta agonists
Fluticasone Salmeterol

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 28, 2014