Conditions: Asthma
Keywords: Asthma Step down therapy Inhaled corticosteroids Long-acting beta agonists Fluticasone Salmeterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 459
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily arm 2: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily arm 3: Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Interventions: intervention 1: Fluticasone/Salmeterol Diskus intervention 2: Fluticasone/Salmeterol Diskus intervention 3: Fluticasone Diskus
Intervention descriptions: intervention 1: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily intervention 2: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily intervention 3: Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Protocol document: