Weekly low-dose @entity1499 for reduction of Global Initiative for XXXX Step 5 treatment in severe refractory @entity565 : study protocol for a randomized controlled trial.

@entity1 @entity748 @entity565 @entity229 @entity348 @entity1500 @entity1499
BACKGROUND: @entity1 with chronic severe @entity565 (CSA) have a crippling disease and current available treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these @entity1 due to major methodologic drawbacks, findings with low-dose @entity1499 ( @entity1500 ) are encouraging. However, larger and well-designed clinical trials are required to establish the beneficial role of @entity1500 in CSA, and for the detection of the key characteristics of those who are going to respond to this drug.Methods/design: @entity1 will be recruited from the accessible @entity748 @entity1 lists of tertiary referral centers. All @entity1 will meet the stringent diagnostic criteria for CSA, including the requirement for the regular use of Global Initiative for @entity565 (GINA) Global Strategy for @entity565 Management and Prevention Step 5 medications (oral @entity229 and/or omalizumab). The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a @entity348 , including run-in and run-out periods. @entity1 will be randomly allocated to receive either @entity1500 or a matched placebo once a week as an add-on therapy to their existing medication after run-in. Physiological, laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments. DISCUSSION: We expect that @entity1500 will reduce Step 5 medications dosage in @entity1 with CSA without compromising the overall disease control. Improvement in several indicators of @entity565 severity and control will be also investigated.Trial registration: ClinicalTrials.gov Identifier: NCT02124226 (assigned 25 April 2014).
