Back to resultsLong-acting Beta Agonist Step Down Study (LASST)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone/Salmeterol Diskus
Fluticasone/Salmeterol Diskus
Fluticasone Diskus
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Step down therapy, Inhaled corticosteroids, Long-acting beta agonists, Fluticasone Salmeterol
Eligibility 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 (forced expiratory volume in 1 second) 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 (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
Sites / Locations
- University of Arizona, Arizona Respiratory Center
- University of California, San Diego
- National Jewish Health
- Nemours Children's Clinic
- University of Miami/University of South Florida
- The Illinois Consortium
- St. Vincent Healthcare
- St. Vincent Hospital and Health Care Center, Inc
- Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center
- University of Missouri, Kansas City School of Medicine
- Washington University/St. Louis University
- Hofstra North Shore-LIJ School of Medicine
- New York University School of Medicine
- Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College
- Duke University Medical Center
- The Ohio State University Medical Center
- Baylor College of Medicine
- Northern New England Consortium
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fluticasone/Salmeterol Diskus 250/50 ug
Fluticasone/Salmeterol Diskus 100/50 ug
Fluticasone Diskus alone 250 ug
Arm Description
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pulmonary Function- Change in Peak Expiratory Flow
Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)
Rate of Episodes of Poor Asthma Control
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 peak expiratory flow rate
Change in Pulmonary Function: FEV1 and FVC
Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.
Pulmonary Function: Change in FEV1/FVC Ratio
Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.
Full Information
NCT ID
NCT01437995
First Posted
September 5, 2011
Last Updated
March 14, 2017
Sponsor
Johns Hopkins University
Collaborators
American Lung Association, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01437995
Brief Title
Long-acting Beta Agonist Step Down Study
Acronym
LASST
Official Title
Long-acting Beta Agonist Step Down Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
American Lung Association, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Step down therapy, Inhaled corticosteroids, Long-acting beta agonists, Fluticasone Salmeterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluticasone/Salmeterol Diskus 250/50 ug
Arm Type
Active Comparator
Arm Description
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Arm Title
Fluticasone/Salmeterol Diskus 100/50 ug
Arm Type
Active Comparator
Arm Description
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Arm Title
Fluticasone Diskus alone 250 ug
Arm Type
Active Comparator
Arm Description
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol Diskus
Other Intervention Name(s)
Fluticasone, Salmeterol
Intervention Description
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol Diskus
Other Intervention Name(s)
Fluticasone, Salmeterol
Intervention Description
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone Diskus
Other Intervention Name(s)
Fluticasone
Intervention Description
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Primary Outcome Measure Information:
Title
Treatment Failure
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Pulmonary Function- Change in Peak Expiratory Flow
Description
Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)
Time Frame
Baseline and 48 weeks
Title
Rate of Episodes of Poor Asthma Control
Description
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 peak expiratory flow rate
Time Frame
48 weeks
Title
Change in Pulmonary Function: FEV1 and FVC
Description
Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.
Time Frame
Baseline and 48 weeks
Title
Pulmonary Function: Change in FEV1/FVC Ratio
Description
Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.
Time Frame
Baseline and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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 (forced expiratory volume in 1 second) 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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Wise, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Linda Rogers, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona, Arizona Respiratory Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
The Illinois Consortium
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Vincent Healthcare
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Missouri, Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University/St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hofstra North Shore-LIJ School of Medicine
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northern New England Consortium
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29863899
Citation
DiMango 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.
Results Reference
derived
Links:
URL
http://www.lungusa.org/
Description
American Lung Association
Learn more about this trial
Long-acting Beta Agonist Step Down Study
We'll reach out to this number within 24 hrs