Corcoran Timothy E, Godovchik Joseph E, Donn Karl H, Busick David R, Goralski Jennifer, Locke Landon W, Markovetz Matthew R, Myerburg Michael M, Muthukrishnan Ashok, Weber Lawrence, Lacy Ryan T, Pilewski Joseph M
Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Parion Sciences, Durham, North Carolina.
Pediatr Pulmonol. 2017 Sep;52(9):1142-1149. doi: 10.1002/ppul.23749. Epub 2017 Jul 24.
Inhaled hypertonic saline increases mucociliary clearance, improves pulmonary function, and decreases exacerbations in cystic fibrosis (CF) but contributes to the already significant treatment burden of CF. Overnight delivery of inhaled medications via a specially designed nasal cannula-aerosol device (Trans-nasal Pulmonary Aerosol Delivery [tPAD]) is an alternative approach. Here, we test whether overnight inhalation of hypertonic saline via tPAD improves mucociliary clearance and assess the tolerability of the device.
In this study, 12 CF subjects inhaled 7% hypertonic saline (HS) for 8 h overnight using the tPAD system. Safety and tolerability were assessed and measurements of mucociliary and absorptive clearance (MCC/ABS) were performed after the treatment. Comparisons were made versus sham treatment where the same subjects wore the nasal cannula overnight but did not receive aerosol.
Both the HS and sham treatments were well-tolerated. Only one subject did not complete the overnight HS treatment. There were no significant differences in MCC associated with HS inhalation at any time point (90 min, 3 h, 6 h) in any lung zone. Changes in FEV on both study days were similar. There were no differences in quality of sleep between HS and sham nights as assessed with the modified Leeds Sleep Evaluation Questionnaire (mLSEQ). Sino-Nasal Outcome Test (SNOT-14) questionnaires demonstrated significant increases (worsening) in 2/14 symptom categories with HS.
The most likely cause for the failure to accelerate MCC was under-dosing of HS relative to the active transport of salt from the airways.
吸入高渗盐水可增加黏液纤毛清除率、改善肺功能并减少囊性纤维化(CF)的急性加重,但这会加重CF患者本就沉重的治疗负担。通过一种特殊设计的鼻插管 - 气雾剂装置(经鼻肺部气雾剂给药[tPAD])进行夜间吸入给药是一种替代方法。在此,我们测试通过tPAD夜间吸入高渗盐水是否能改善黏液纤毛清除率,并评估该装置的耐受性。
在本研究中,12名CF受试者使用tPAD系统夜间吸入7%高渗盐水(HS)8小时。评估安全性和耐受性,并在治疗后进行黏液纤毛和吸收清除率(MCC/ABS)测量。将其与假治疗进行比较,即相同受试者夜间佩戴鼻插管但不接受气雾剂。
HS治疗和假治疗耐受性均良好。只有一名受试者未完成夜间HS治疗。在任何肺区的任何时间点(90分钟、3小时、6小时),与吸入HS相关的MCC均无显著差异。两个研究日的第一秒用力呼气容积(FEV)变化相似。用改良的利兹睡眠评估问卷(mLSEQ)评估,HS夜间和假治疗夜间的睡眠质量无差异。鼻窦结局测试(SNOT - 14)问卷显示,HS治疗后14种症状类别中有2种显著增加(恶化)。
未能加速MCC的最可能原因是相对于气道中盐的主动转运,HS给药剂量不足。