Long-acting Beta Agonist Step Down Study (LASST)
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ClinicalTrials.gov Identifier: NCT01437995 |
Recruitment Status :
Completed
First Posted : September 21, 2011
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: Fluticasone/Salmeterol Diskus Drug: Fluticasone Diskus | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Fluticasone/Salmeterol Diskus 250/50 ug
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
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Drug: Fluticasone/Salmeterol Diskus
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Other Names:
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Active Comparator: Fluticasone/Salmeterol Diskus 100/50 ug
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
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Drug: Fluticasone/Salmeterol Diskus
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Other Names:
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Active Comparator: Fluticasone Diskus alone 250 ug
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
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Drug: Fluticasone Diskus
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Other Name: Fluticasone |
- 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.
- 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)
- 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
- 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.
- 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.

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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 |
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

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

Study Director: | Robert A Wise, MD | Johns Hopkins University | |
Principal Investigator: | Linda Rogers, MD | NYU Langone Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Asthma Step down therapy Inhaled corticosteroids Long-acting beta agonists Fluticasone Salmeterol |
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 |