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Long-acting Beta Agonist Step Down Study (LASST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01437995
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
American Lung Association
GlaxoSmithKline
Information provided by (Responsible Party):
Robert A. Wise, Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone/Salmeterol Diskus Drug: Fluticasone Diskus Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Long-acting Beta Agonist Step Down Study
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Failure [ Time Frame: 48 weeks ]
    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 :
  1. Pulmonary Function- Change in Peak Expiratory Flow [ Time Frame: Baseline and 48 weeks ]
    Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)

  2. Rate of Episodes of Poor Asthma Control [ Time Frame: 48 weeks ]
    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

  3. Change in Pulmonary Function: FEV1 and FVC [ Time Frame: Baseline and 48 weeks ]
    Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.

  4. Pulmonary Function: Change in FEV1/FVC Ratio [ Time Frame: Baseline and 48 weeks ]
    Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437995


Locations
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Sponsors and Collaborators
Johns Hopkins University
American Lung Association
GlaxoSmithKline
Investigators
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Study Director: Robert A Wise, MD Johns Hopkins University
Principal Investigator: Linda Rogers, MD NYU Langone Health
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert A. Wise, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01437995    
Other Study ID Numbers: ADV115922
First Posted: September 21, 2011    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017
Keywords provided by Robert A. Wise, Johns Hopkins University:
Asthma
Step down therapy
Inhaled corticosteroids
Long-acting beta agonists
Fluticasone Salmeterol
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones