Long-acting Beta Agonist Step Down Study

Asthma Clinical Trial

— LASST  

Official title:

Long-acting Beta Agonist Step Down Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437995
• Other study ID #: ADV115922
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2011
• Last updated: February 26, 2016
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 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 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 CHF, unstable angina, recent MI, 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone/Salmeterol Diskus
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
• Fluticasone/Salmeterol Diskus
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
• Fluticasone Diskus
Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	The Illinois Consortium	Chicago	Illinois
United States	Northern New England Consortium	Colchester	Vermont
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	St. Vincent Healthcare	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center, Inc	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Missouri, Kansas City School of Medicine	Kansas City	Missouri
United States	Hofstra North Shore-LIJ School of Medicine	New Hyde Park	New York
United States	Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center	New Orleans	Louisiana
United States	New York University School of Medicine	New York	New York
United States	University of California, San Diego	San Diego	California
United States	Washington University/St. Louis University	St. Louis	Missouri
United States	University of Miami/University of South Florida	Tampa	Florida
United States	University of Arizona, Arizona Respiratory Center	Tucson	Arizona
United States	Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College	Valhalla	New York

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	American Lung Association, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pulmonary Function	Pulmonary function measures: 1)morning peak expiratory flow rate (from the patients' daily diary cards) and 2)pre-BD FEV1 and bronchodilator response	48 weeks	Yes
Secondary	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 PEFR	48 weeks	Yes

External Links

•   American Lung Association