NCT01437995.

Trial name or title	Long‐acting Beta Agonist Step Down Study (LASST)
Methods	56‐week, multicentre, blinded, randomised, double‐masked parallel group comparative effectiveness study of approaches to stepping down therapy for people with well‐controlled asthma treated with combination ICS and LABA.
Participants	Inclusion Criteria: males and females aged 12‐80 years with well‐controlled asthma on moderate dose ICS/LABA based on an Asthma Control Test score ≥ 20, absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrolment and a pre‐bronchodilator FEV1 ≥ 70% predicted Exclusion Criteria: chronic oral steroid therapy, hospitalisation 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, post‐bronchodilator FEV1 < 70% predicted, near fatal asthma (intubation or ICU admission for asthma) within 2 yrs of enrolment, 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, drug allergies, pregnancy, lactation
Interventions	Stepping down from fluticasone/salmeterol Diskus 250/50 mcg twice a day to fluticasone Diskus 250 mcg twice a day without salmeterol
Outcomes	Primary: Rate of treatment failures (decline in peak flow or FEV1, increased need for beta agonists, requirement for non‐scheduled medical care for asthma symptoms, or prednisone taper) Secondary: Pulmonary function (morning peak expiratory flow, pre‐bronchodilator FEV1), episodes of poor asthma control defined by unscheduled medical care, hospitalisation, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate
Starting date	March 2012
Contact information	Joy Saams, Registered Nurse
Notes	Estimated enrolment: 450. Estimated study completion date: June 2015 May be able to obtain data for children and adolescents separately from the adult participants