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1</a>&#41; simulated an adult breathing pattern &#40;Vt<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>500<span class="elsevierStyleHsp" style=""></span>mL-RF<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>12<span class="elsevierStyleHsp" style=""></span>breaths&#47;min-<span class="elsevierStyleItalic">I</span>&#47;<span class="elsevierStyleItalic">E</span> ratio<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>1&#58;2-breath-hold time<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;25<span class="elsevierStyleHsp" style=""></span>s&#41;&#46; An absolute bacterial&#47;viral filter &#40;Air Safety Ltd&#44; Lancashire&#41; was placed between the lung model and NEB-OPEP&#47;NEB to measure the inhaled dose &#40;IND&#41;&#46; Another filter placed on the expiratory port collected the exhaled dose &#40;ExD&#41;&#46; The mass of amikacin collected on filters during nebulization was quantified using the residual gravimetric method&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a> The nebulizer output was calculated by dividing the IND by the nebulization duration&#46; The residual volume was quantified&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">In the in vivo part&#44; after ethical approval &#40;B40320107908&#41; and registration of the trial &#40;<a href="ctgov:NCT02535130">NCT02535130</a>&#41;&#44; six non-smoker healthy males were recruited&#46; They signed a written informed consent form&#46; They were excluded if they received any antibiotic or aerosolized drug during the month preceding the experiments&#44; for history of cardiovascular and&#47;or pulmonary disease&#44; for allergy to aminoglycosides and for abnormal pulmonary function&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">After &#40;1&#41; selection visit&#44; spirometry and medical examination and &#40;2&#41; training to inhale correctly&#44; &#40;3&#41; inhalation and &#40;4&#41; urine sampling were performed&#46; Each subject repeated the steps 3 and 4 in similar conditions using a randomized crossover setting &#40;<a href="http://www.randomizer.org/">www&#46;randomizer&#46;org</a>&#41; with a one-week washout period between the two configurations &#40;NEB or NEB-OPEP&#41;&#46; The subjects breathed spontaneously through mouthpiece wearing a noseclip&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Just before the experiments&#44; the urinary bladder of the subjects was emptied&#46; Then&#44; urine samples were collected at each spontaneous micturition during the 24<span class="elsevierStyleHsp" style=""></span>h following the nebulization&#46; The volume and timing of micturition were recorded&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">After sampling by fluorescence polarization immuno-assay&#44; the total daily amount of amikacin excreted in the urine &#40;Cu max&#41; reflecting lung deposition and the elimination rate constant was calculated using the Michaelis&#8211;Menten kinetic model from cumulating amikacin amount measured at each micturition &#40;Cu&#41; and represents the lung dose &#40;LD&#41; &#40;Cu max<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>Cu<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>&#40;1<span class="elsevierStyleHsp" style=""></span>&#8722;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">e</span><span class="elsevierStyleSup">&#8722;<span class="elsevierStyleItalic">Ke</span>&#183;<span class="elsevierStyleItalic">x</span>&#183;<span class="elsevierStyleItalic">t</span></span>&#41;&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The residual amount of drug was calculated by multiplying residual volume and its final concentration&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">In vitro&#44; no difference was found between NEB and NEB-OPEP for IND &#40;34&#46;4&#37; &#40;30&#46;0&#8211;38&#46;0&#41; vs 29&#46;6&#37; &#40;26&#46;8&#8211;32&#46;0&#41;&#41; and ExD &#40;20&#46;8 &#40;19&#46;6&#8211;23&#46;2&#41; vs 25&#46;2&#37; &#40;22&#46;4&#8211;28&#46;4&#41;&#41;&#46; Nebulizer output was higher for NEB than for NEB-OPEP &#40;1&#46;49<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;14 vs 1&#46;10<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;12<span class="elsevierStyleHsp" style=""></span>mL<span class="elsevierStyleHsp" style=""></span>min<span class="elsevierStyleSup">&#8722;1</span>&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;032&#41;&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Six subjects completed the study &#40;21&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;0 y &#8211; 179&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;8<span class="elsevierStyleHsp" style=""></span>cm &#8211; 76&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>11&#46;7<span class="elsevierStyleHsp" style=""></span>kg &#8211; FEV1&#58; 97<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#37;&#41;&#46; The lung dose was reduced by 40&#37; and the time required to finish the nebulization was 1&#46;2<span class="elsevierStyleHsp" style=""></span>min longer with NEB-OPEP than with NEB &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">Lung delivery around 5&#37; of the ND with NEB confirmed previous results&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">8</span></a> In addition&#44; our results showed that interposing this new OPEP device between the nebulizer and the patient&#39;s mouth reduced the efficiency of the nebulization similarly to results found with other PEP devices under different conditions&#46;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">9&#44;10</span></a> This is clinically important when dose-dependent drugs are administered&#46; The reduced lung delivery could be explained by the impaction of particles in the PEP device that filters the larger particles&#46;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">9&#44;11</span></a> However&#44; this hypothesis was neither verified in our study &#40;similar IND and ExD&#41; nor in a previous study&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">12</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">The duration of the nebulization was inversely related to the adherence in CF<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">13</span></a> and it is therefore considered as a key factor for an optimal treatment&#46;<a class="elsevierStyleCrossRefs" href="#bib0170"><span class="elsevierStyleSup">14&#44;15</span></a> In the present study&#44; the small increase in time &#40;&#43;1&#46;2<span class="elsevierStyleHsp" style=""></span>min&#41; related to the NEB-OPEP is compensated by the time saved on the total duration of the treatment administered separately &#40;3&#46;1<span class="elsevierStyleHsp" style=""></span>min&#41;&#46; This advantage could be important for the patients needing several daily sessions&#46; However&#44; as suggested by our results&#44; the necessity to nearly double the nebulization duration to reach a similar lung delivery with NEB-OPEP must be taken into account&#46; As Berlinsky showed variable delivery depending on the PEP devices&#44;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> each configuration must be evaluated&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The modified pattern of breathing related to PEP is unfavorable to the nebulization function and explains probably the worst lung delivery related to the combination&#46; The reduction in breathing frequency &#40;7&#46;8 cycles by minutes&#41; when healthy subjects used PEP mask could be considered as advantageous<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">16</span></a> but it was associated to a prolonged expiration that contributes to loose particles during the expiratory phase&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">17</span></a> The concomitant reduction in the inspiratory&#8211;expiratory ratio contributes certainly to the reduced lung delivery by losing particles during the expiratory phase and it can explain the difference with in vitro results&#46; Some particles are probably exhaled and others are delivered in the atmosphere or the device during this phase&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Some limitations of the study should be discussed&#46; First&#44; the nebulizer was placed at the distal outlet of the PEP device&#46; This configuration is less efficient than that in which the proximal outlet is used for connection&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">10</span></a> although the latter is recommended by the manufacturer&#46; Second&#44; testing healthy subjects omits the clinical and pathophysiological outcomes related to positive expiratory pressure and its oscillations but it permits to evaluate the nebulization function<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">8&#44;18&#44;19</span></a> and reduces the variability resulting from mucus plugging or lung disease&#46; Furthermore&#44; even if lung delivery in healthy subjects cannot be extrapolated to patients with respiratory diseases&#44; a similar lung deposition was recently found between healthy subjects and patients with CF&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">20</span></a> Third&#44; each subject was its own control to reduce anatomical&#44; anthropometrical and respiratory influences on lung delivery&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">This study suggests that connecting Aerobika at the proximal outlet of a nebulizer is less efficient than using the nebulization alone for drug delivery&#46; However&#44; the gain in time is an argument in favor of the combination&#46;</p></span>"
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Time of nebulization &#40;min&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Residual volume &#40;mL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;85<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;08&nbsp;\t\t\t\t\t\t\n
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Scientific letter
In Vitro and In Vivo Evaluation of the Combination of Oscillating Positive Expiratory Pressure and Nebulization: A Randomized Cross-Over Study
Evaluación in vitro e in vivo de la combinación de presión espiratoria positiva oscilante y nebulización: estudio aleatorizado cruzado
Gregory Reychlera,b,c,
Corresponding author
gregory.reychler@uclouvain.be

Corresponding author.
, Teresinha Leald, Anne-Sophie Aubriotb,e, Giuseppe Liistroa,c
a Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Belgium
b Service de Médecine Physique et Réadaptation, Cliniques universitaires Saint-Luc, Belgium
c Service de Pneumologie, Cliniques universitaires Saint-Luc, Belgium
d Louvain Centre for Toxicology and Applied Pharmacology, Institut de Recherche Expérimentale et Clinique, Secteur des Sciences de la Santé, Université Catholique de Louvain, Belgium
e Centre de Référence pour la Mucoviscidose, Cliniques universitaires Saint-Luc, Belgium
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the total daily amount of amikacin excreted in the urine &#40;Cu max&#41; reflecting lung deposition and the elimination rate constant was calculated using the Michaelis&#8211;Menten kinetic model from cumulating amikacin amount measured at each micturition &#40;Cu&#41; and represents the lung dose &#40;LD&#41; &#40;Cu max<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>Cu<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>&#40;1<span class="elsevierStyleHsp" style=""></span>&#8722;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">e</span><span class="elsevierStyleSup">&#8722;<span class="elsevierStyleItalic">Ke</span>&#183;<span class="elsevierStyleItalic">x</span>&#183;<span class="elsevierStyleItalic">t</span></span>&#41;&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The residual amount of drug was calculated by multiplying residual volume and its final concentration&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">In vitro&#44; 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179&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;8<span class="elsevierStyleHsp" style=""></span>cm &#8211; 76&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>11&#46;7<span class="elsevierStyleHsp" style=""></span>kg &#8211; FEV1&#58; 97<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#37;&#41;&#46; The lung dose was reduced by 40&#37; and the time required to finish the nebulization was 1&#46;2<span class="elsevierStyleHsp" style=""></span>min longer with NEB-OPEP than with NEB &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">Lung delivery around 5&#37; of the ND with NEB confirmed previous results&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">8</span></a> In addition&#44; our results showed that interposing this new OPEP device between the nebulizer and the patient&#39;s mouth reduced the efficiency of the nebulization similarly to results found with other PEP devices under different conditions&#46;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">9&#44;10</span></a> This is clinically important when dose-dependent drugs are administered&#46; The reduced lung delivery could be explained by the impaction of particles in the PEP device that filters the larger particles&#46;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">9&#44;11</span></a> However&#44; this hypothesis was neither verified in our study &#40;similar IND and ExD&#41; nor in a previous study&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">12</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">The duration of the nebulization was inversely related to the adherence in CF<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">13</span></a> and it is therefore considered as a key factor for an optimal treatment&#46;<a class="elsevierStyleCrossRefs" href="#bib0170"><span class="elsevierStyleSup">14&#44;15</span></a> In the present study&#44; the small increase in time &#40;&#43;1&#46;2<span class="elsevierStyleHsp" style=""></span>min&#41; related to the NEB-OPEP is compensated by the time saved on the total duration of the treatment administered separately &#40;3&#46;1<span class="elsevierStyleHsp" style=""></span>min&#41;&#46; This advantage could be important for the patients needing several daily sessions&#46; However&#44; as suggested by our results&#44; the necessity to nearly double the nebulization duration to reach a similar lung delivery with NEB-OPEP must be taken into account&#46; As Berlinsky showed variable delivery depending on the PEP devices&#44;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> each configuration must be evaluated&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The modified pattern of breathing related to PEP is unfavorable to the nebulization function and explains probably the worst lung delivery related to the combination&#46; The reduction in breathing frequency &#40;7&#46;8 cycles by minutes&#41; when healthy subjects used PEP mask could be considered as advantageous<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">16</span></a> but it was associated to a prolonged expiration that contributes to loose particles during the expiratory phase&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">17</span></a> The concomitant reduction in the inspiratory&#8211;expiratory ratio contributes certainly to the reduced lung delivery by losing particles during the expiratory phase and it can explain the difference with in vitro results&#46; Some particles are probably exhaled and others are delivered in the atmosphere or the device during this phase&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Some limitations of the study should be discussed&#46; First&#44; the nebulizer was placed at the distal outlet of the PEP device&#46; This configuration is less efficient than that in which the proximal outlet is used for connection&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">10</span></a> although the latter is recommended by the manufacturer&#46; Second&#44; testing healthy subjects omits the clinical and pathophysiological outcomes related to positive expiratory pressure and its oscillations but it permits to evaluate the nebulization function<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">8&#44;18&#44;19</span></a> and reduces the variability resulting from mucus plugging or lung disease&#46; Furthermore&#44; even if lung delivery in healthy subjects cannot be extrapolated to patients with respiratory diseases&#44; a similar lung deposition was recently found between healthy subjects and patients with CF&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">20</span></a> Third&#44; each subject was its own control to reduce anatomical&#44; anthropometrical and respiratory influences on lung delivery&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">This study suggests that connecting Aerobika at the proximal outlet of a nebulizer is less efficient than using the nebulization alone for drug delivery&#46; However&#44; the gain in time is an argument in favor of the combination&#46;</p></span>"
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Time of nebulization &#40;min&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Residual volume &#40;mL&#41;&nbsp;\t\t\t\t\t\t\n
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ISSN: 15792129
Original language: English
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