AsthmaPhase 4LASSTNCT01437995

Long-acting Beta Agonist Step Down Study

A Phase 4 study testing Fluticasone/Salmeterol Diskus and Fluticasone Diskus in people with Asthma, run by Johns Hopkins University at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Fluticasone/Salmeterol Diskus and Fluticasone Diskus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 459 participants
Where: 19 sitesUnited States
Study dates: Mar 2012to Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

University of Virginia
Charlottesville, Virginia, 22908
The Illinois Consortium
Chicago, Illinois, 60611
Northern New England Consortium
Colchester, Vermont, 05446
The Ohio State University Medical Center
Columbus, Ohio, 43221
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
St. Vincent Healthcare
Indianapolis, Indiana, 46260
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, 46290
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108
Hofstra North Shore-LIJ School of Medicine
New Hyde Park, New York, 11040
Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center
New Orleans, Louisiana, 70112
New York University School of Medicine
New York, New York, 10016
University of California, San Diego
San Diego, California, 92103
Washington University/St. Louis University
St Louis, Missouri, 63110
University of Miami/University of South Florida
Tampa, Florida, 33613
University of Arizona, Arizona Respiratory Center
Tucson, Arizona, 85724
Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College
Valhalla, New York, 10595

Other trials in United States

About this study

Read the 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.

Conditions: Asthma
Being tested: Fluticasone/Salmeterol Diskus, Fluticasone Diskus
Keywords: Asthma, Step down therapy, Inhaled corticosteroids, Long-acting beta agonists, Fluticasone Salmeterol
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone/Salmeterol DiskusDrug
Also called Fluticasone, Salmeterol
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol DiskusDrug
Also called Fluticasone, Salmeterol
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone DiskusDrug
Also called Fluticasone
Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Study groups in NCT01437995
Study group	Role	What they receive
Fluticasone/Salmeterol Diskus 250/50 ug	Active comparator	Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily Receives: Drug: Fluticasone/Salmeterol Diskus
Fluticasone/Salmeterol Diskus 100/50 ug	Active comparator	Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily Receives: Drug: Fluticasone/Salmeterol Diskus
Fluticasone Diskus alone 250 ug	Active comparator	Fluticasone Diskus alone 250 ug twice daily without Salmeterol Receives: Drug: Fluticasone Diskus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 48 weeks

Secondary outcomes (4)

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)
Measured: Baseline and 48 weeks
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
Measured: 48 weeks
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.
Measured: Baseline and 48 weeks
Pulmonary Function: Change in FEV1/FVC Ratio
Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.
Measured: Baseline and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Oct 2015

First posted21 Sep 2011 (estimated)
Study startMar 2012
Primary completionSep 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01437995
Sponsor's protocol ID: ADV115922
Acronym: LASST
Status last verified: Mar 2017
First submitted: 5 Sep 2011
Last updated: 25 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 37347518
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.
PubMed 29863899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-acting Beta Agonist Step Down Study
ClinicalTrials.gov ID: NCT01437995
Acronym / sponsor ID: LASST / ADV115922
Conditions: Asthma
Keywords: Asthma, Step down therapy, Inhaled corticosteroids, Long-acting beta agonists, Fluticasone Salmeterol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: American Lung Association, GlaxoSmithKline
Study start: Mar 2012
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 21 Sep 2011 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Fluticasone/Salmeterol Diskus 250/50 ug	Active comparator	Drug: Fluticasone/Salmeterol DiskusContinuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus 100/50 ug	Active comparator	Drug: Fluticasone/Salmeterol DiskusReduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone Diskus alone 250 ug	Active comparator	Drug: Fluticasone DiskusFluticasone Diskus alone 250 ug twice daily without Salmeterol

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone/Salmeterol DiskusAlso: Fluticasone, SalmeterolContinuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily	Drug	Fluticasone/Salmeterol Diskus 250/50 ug
Fluticasone/Salmeterol DiskusAlso: Fluticasone, SalmeterolReduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily	Drug	Fluticasone/Salmeterol Diskus 100/50 ug
Fluticasone DiskusAlso: FluticasoneFluticasone Diskus alone 250 ug twice daily without Salmeterol	Drug	Fluticasone Diskus alone 250 ug

Primary outcome

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.

4 secondary outcomes

Pulmonary Function- Change in Peak Expiratory Flow
Time frame: Baseline and 48 weeks
Rate of Episodes of Poor Asthma Control
Time frame: 48 weeks
Change in Pulmonary Function: FEV1 and FVC
Time frame: Baseline and 48 weeks
Pulmonary Function: Change in FEV1/FVC Ratio
Time frame: Baseline and 48 weeks

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stable ICS-LABA	151	140
Reduced ICS/LABA	149	131
LABA Step Off	155	135

Primary outcome: Treatment Failure

Time frame: 48 weeks. Number. Unit: participants

Measure	Stable ICS-LABA n = 150	Reduced ICS/LABA n = 146	LABA Step Off n = 151
Value	38	39	45

Stable ICS-LABA vs Reduced ICS/LABA vs LABA Step Off: Hazard Ratio (HR): 1.07 (95.3% CI 0.69 to 1.65)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stable ICS-LABA	7 of 151 (4.6%)	110 of 151 (72.8%)	Not reported
Reduced ICS/LABA	3 of 149 (2%)	102 of 149 (68.5%)	Not reported
LABA Step Off	15 of 155 (9.7%)	100 of 155 (64.5%)	Not reported

Limitations and caveats (from the sponsor): At the time of this release, this data has not undergone peer-review.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37347518Blake 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.
Derived from this study: PubMed 29863899DiMango 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.
American Lung AssociationLink provided by the sponsor.

Related trials for Asthma

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RecruitingPhase 3
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Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert A Wise, MD study director

Johns Hopkins University

Linda Rogers, MD principal investigator

NYU Langone Health

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone/Salmeterol Diskus and Fluticasone Diskus in people with Asthma, run by Johns Hopkins University at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Failure (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437995, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.