The Effectiveness of Nasal Airway Stent Therapy for the Treatment of Mild-to-Moderate Obstructive Sleep Apnea Syndrome.

BACKGROUND: Patients with obstructive sleep apnea syndrome (OSAS) experience excessive daytime sleepiness and insomnia and they are at risk of developing cardiovascular disease and stroke. Continuous positive airway pressure therapy could improve symptoms and decrease these risks; however, adherence is problematic. Although the oral appliance is another therapeutic option, patient satisfaction is limited and the effect of the nasal airway stent - a new device - remains unclear. OBJECTIVES: The aim of this study was to evaluate the effect of NAS therapy in patients with mild-to-moderate OSAS in a prospective, single-arm, interventional pilot study. METHOD: Patients with mild/moderate sleep apnea (n = 71; Apnea-Hypopnea Index [AHI], 5-20 events/h on polysomnography) were recruited. Sleep-associated events were measured using a portable device (WatchPAT200) pre- and immediately post-treatment and at 1 month follow-up. AHI (including supine and non-supine AHI), Oxygen Desaturation Index (ODI), Respiratory Disturbance Index (RDI), percutaneous oxygen saturation, heart rate, and snore volume were evaluated. Symptoms were assessed using the Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Hospital Anxiety and Depression Scale. RESULTS: NAS use significantly improved AHI, supine AHI, RD, ODI, and snore volume compared to pre-intervention (r = 0.44, 0.48, 0.3, 0.42, and 0.34; p < 0.001, p < 0.001, p = 0.011, p < 0.001, and p = 0.048, respectively). Additionally, 25 and 10% of patients showed complete and partial response for AHI, respectively; these improvements remained significant 1 month later. Pittsburgh Sleep Quality Index scores improved from 6.0 to 5.3 (r = 0.46, p = 0.022). CONCLUSIONS: NAS therapy reduced severity and snoring in patients with mild-to-moderate OSAS. Approximately 30% of patients did not tolerate NAS due to side effects.

Characteristics of severe asthma with fungal sensitization.

BACKGROUND: Some patients with severe asthma also have fungal sensitization and are considered to have severe asthma with fungal sensitization. However, there is limited information on the clinical features of SAFS. OBJECTIVE: To investigate the clinical characteristics of severe asthma with fungal sensitization. METHODS: The present study enrolled 124 patients with severe asthma. We evaluated clinical aspects, such as various serum cytokines, fractional exhaled nitric oxide, pulmonary function, and serum immunoglobulin E (IgE). Fungal sensitization was assessed by determining serum levels of IgE specific to fungal allergens (Aspergillus, Alternaria, Candida, Cladosporium, Penicillium, and Trichophyton species and Schizophyllum commune). The protocol was registered at a clinical trial registry (www.umin.ac.jp/ctr/index-j.htm; UMIN 000002980). RESULTS: Thirty-six patients (29%) showed sensitization to at least 1 fungal allergen. The most common species were Candida (16%), Aspergillus (11%), and Trichophyton (11%). The rate of early-onset asthma (<16 years of age) was higher in patients with fungal sensitization than in those without fungal sensitization (45% vs 25%; P = .02). Interleukin-33 levels were higher in patients with fungal sensitization than in those without fungal sensitization. Of patients with atopic asthma, Asthma Control Test scores were worse in patients with multiple fungal sensitizations than in patients with a single fungal sensitization or those without fungal sensitization. CONCLUSION: Severe asthma with fungal sensitization is characterized by early onset of disease and high serum levels of interleukin-33. Multiple fungal sensitizations are associated with poor asthma control. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR; www.umin.ac.jp/ctr/index-j.htm): UMIN 000002980.

Therapeutic Response to Single-Inhaler Triple Therapies in Moderate-to-Severe COPD.

BACKGROUND: COPD is characterized by progressive and irreversible air flow limitations. Single-inhaler therapies (SITTs) incorporating an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting ß2-agonist have been shown to effectively alleviate symptoms and improve lung function. Fluticasone-furoate/umeclidinium/vilanterol (F/U/V) and budesonide/glycopyrronium/formoterol (B/G/F) are available as SITT in Japan. However, the clinical differences between these 2 combinations and the predictors of their proper use have not been established. This study aimed to identify the subject characteristics that could predict the effectiveness of inhaler therapy. METHODS: We assessed the pulmonary function test results of subjects with COPD before and one month after using F/U/V and B/G/F as SITT. Subjects with a difference of 100 mL or more in the FEV1 after treatment with pre-SITT were extracted and divided into the F/U/V effect and no-effect group and B/G/F effect and no-effect group to examine the factors associated with positive outcomes with each inhaler. RESULTS: F/U/V and B/G/F significantly improved the inspiratory capacity (IC), %IC, FVC, and %FEV1 when compared to pre-intervention values (P < .001, P = .001, P = .007, P = .009, respectively, for F/U/V; and P = .006, P = .008, P = .038, P = .005, respectively, for B/G/F). Factors associated with FEV1 improvement in F/U/V included lower %IC (odds ratio 0.97 [95% CI 0.94-0.99], P = .03) and a higher modified Medical Research Council (mMRC) dyspnea score (2.36 [1.27-4.70], P < .01). In addition, a higher %IC (1.03 [1.00-1.06], P = .02) and lower mMRC dyspnea score (0.55 [0.28-0.99], P = .041) were predictors for the effectiveness of B/G/F. CONCLUSIONS: Our results showed that SITT significantly improved the IC, %IC, FVC, and %FEV1 when compared to pre-intervention and that F/U/V was more effective in subjects with severe symptoms, whereas B/G/F was more effective in subjects with mild symptoms.