The Journal of asthma : official journal of the Association for the Care of Asthma
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Multicenter Study Observational Study
Effectiveness and safety of omalizumab in severe, persistent IgE-mediated asthma in pediatric and adult patients: a real-world observational study in Egyptian population.
Objective: Real-world studies on the effectiveness of omalizumab in Egyptian population with asthma are limited. This study aimed to evaluate the real-world effectiveness and safety of omalizumab as an add-on treatment in pediatric and adult patients with severe, persistent allergic asthma in Egypt. Methods: The primary endpoint of this 16-week, prospective, open-label, multicenter, non-interventional study was the reduction in oral corticosteroid (OCS) dose. ⋯ No new safety signals were observed in the safety analysis of omalizumab as add-on treatment. Conclusions: Outcomes of this real-world study were consistent with previous effectiveness and safety studies of omalizumab. Omalizumab was effective and well tolerated for the management of severe, persistent IgE-mediated asthma in pediatric and adult patients in Egypt.
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Multicenter Study
Enhancing guideline-based asthma care processes through a multi-state, multi-center quality improvement program.
This study investigated the effectiveness of Enhancing Care for Patients with Asthma (ECPA)-a collaborative quality improvement program implemented in 65 community health centers that serve asthma patients in four states-on clinic-based asthma performance measures consistent with national guidelines. ⋯ This study demonstrated the favorable effect of the ECPA program on evidence-based asthma quality measures. This program could be considered a model worth replication on a broader scale.
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Randomized Controlled Trial Multicenter Study
Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA.
We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β2 agonist (ICS/LABA). ⋯ FF/VI was non-inferior to FP/SAL for evening trough FEV1 at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.
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Randomized Controlled Trial Multicenter Study
Fluticasone/formoterol combination therapy versus budesonide/formoterol for the treatment of asthma: a randomized, controlled, non-inferiority trial of efficacy and safety.
The inhaled corticosteroid fluticasone propionate (fluticasone) and the long-acting β₂ agonist formoterol fumarate (formoterol) have been combined in a single aerosol inhaler fluticasone/formoterol (flutiform(®)). This study compared the efficacy and safety of fluticasone/formoterol with the combination product budesonide/formoterol (Symbicort(®) Turbohaler(®)). ⋯ This study demonstrated comparable efficacy of fluticasone/formoterol to budesonide/formoterol in terms of the primary endpoint, change in pre-dose FEV₁ from baseline to Week 12. This was supported by comparable results for both treatments for all secondary endpoints.
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Randomized Controlled Trial Multicenter Study
The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients.
In Japan, the Asthma Prevention and Management Guidelines recommend nebulized β-agonists, IV (intravenous) drip corticosteroids, as well as IV drip aminophylline for acute asthma treatment. However, current treatment for acute asthma provides inadequate benefit for some patients. We evaluated the efficacy and safety of IV montelukast added to standard therapy in Japanese patients with acute asthma exacerbations. ⋯ IV montelukast was significantly more effective than placebo in the improvement of ΔFEV(1) in Japanese patients, suggesting its role as an adjunctive therapy to existing guideline recommendations.