Long-acting Beta Agonist Step Down Study

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01437995

Run by

Johns Hopkins University

People needed

459

Starts

2012-03-01

Expected to finish

2015-10-01

Last updated by the study team

2017-04-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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