Long-acting Beta Agonist Step Down Study
LASST
1 other identifier
interventional
459
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Mar 2012
Longer than P75 for phase_4 asthma
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2011
CompletedFirst Posted
Study publicly available on registry
September 21, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
March 1, 2017
3.5 years
September 5, 2011
October 7, 2016
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Failure
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.
48 weeks
Secondary Outcomes (4)
Pulmonary Function- Change in Peak Expiratory Flow
Baseline and 48 weeks
Rate of Episodes of Poor Asthma Control
48 weeks
Change in Pulmonary Function: FEV1 and FVC
Baseline and 48 weeks
Pulmonary Function: Change in FEV1/FVC Ratio
Baseline and 48 weeks
Study Arms (3)
Fluticasone/Salmeterol Diskus 250/50 ug
ACTIVE COMPARATORContinuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus 100/50 ug
ACTIVE COMPARATORReduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone Diskus alone 250 ug
ACTIVE COMPARATORFluticasone Diskus alone 250 ug twice daily without Salmeterol
Interventions
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Eligibility Criteria
You may qualify if:
- 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 (forced expiratory volume in 1 second) more than or equal to 70% predicted
You may not qualify if:
- 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 (chronic obstructive pulmonary disease) 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 congestive heart failure, unstable angina, recent myocardial infarction, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- American Lung Associationcollaborator
- GlaxoSmithKlinecollaborator
Study Sites (19)
University of Arizona, Arizona Respiratory Center
Tucson, Arizona, 85724, United States
University of California, San Diego
San Diego, California, 92103, United States
National Jewish Health
Denver, Colorado, 80206, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University of Miami/University of South Florida
Tampa, Florida, 33613, United States
The Illinois Consortium
Chicago, Illinois, 60611, United States
St. Vincent Healthcare
Indianapolis, Indiana, 46260, United States
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, 46290, United States
Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center
New Orleans, Louisiana, 70112, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Washington University/St. Louis University
St Louis, Missouri, 63110, United States
Hofstra North Shore-LIJ School of Medicine
New Hyde Park, New York, 11040, United States
New York University School of Medicine
New York, New York, 10016, United States
Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Ohio State University Medical Center
Columbus, Ohio, 43221, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Northern New England Consortium
Colchester, Vermont, 05446, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (2)
Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.
PMID: 37347518DERIVEDDiMango E, Rogers L, Reibman J, Gerald LB, Brown M, Sugar EA, Henderson R, Holbrook JT. Risk Factors for Asthma Exacerbation and Treatment Failure in Adults and Adolescents with Well-controlled Asthma during Continuation and Step-Down Therapy. Ann Am Thorac Soc. 2018 Aug;15(8):955-961. doi: 10.1513/AnnalsATS.201711-886OC.
PMID: 29863899DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
At the time of this release, this data has not undergone peer-review.
Results Point of Contact
- Title
- Alexis Rea
- Organization
- Johns Hopkins University
Study Officials
- STUDY DIRECTOR
Robert A Wise, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Linda Rogers, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 5, 2011
First Posted
September 21, 2011
Study Start
March 1, 2012
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-03