Long-acting Beta Agonist Step Down Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone/Salmeterol Diskus; Fluticasone/Salmeterol Diskus; Fluticasone Diskus
Intervention description: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily; Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily; Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Step down therapy; Inhaled corticosteroids; Long-acting beta agonists; Fluticasone Salmeterol

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.
    

Eligibility criteria:

        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