Lung Deposition of Alpha1-Proteinase Inhibitor (Human) (A1-PI[H]) Inhalation Solution Using Two Inhalation Modes of the I-neb Adaptive Aerosol Delivery (AAD) System in Healthy Subjects and Subjects with Cystic Fibrosis

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 29, Issue 3, 2016, Pages 242-250

  Häussermann, Sabine ^a   Winnips, Cornelis ^b   Edelman, Jonathan ^c   Kappeler, Dominik ^a   Herpich, Christiane ^a   Ehlich, Hilke ^a   Zanker, Daniela ^a   Kietzig, Claudius ^a   Sommerer, Knut ^a  

^a Inamed GmbH   (Germany)

^b CSL Behring AG   (Switzerland)

^c CSL Behring LLC   (United States)

Author keywords

alpha 1 antitrypsin; alpha1 proteinase inhibitor; cystic fibrosis; I neb AAD System; inhaled drug; lung deposition; lung imaging; nebulizer; pulmonary function testing; scintigraphy

Indexed keywords

ALPHA 1 ANTITRYPSIN; AEROSOL; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; SERPINA1 PROTEIN, HUMAN;

ABSENCE OF SIDE EFFECTS; ADULT; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; CYSTIC FIBROSIS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HOME NEBULIZER; HUMAN; INHALATION; ISOTOPE LABELING; MALE; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TARGET INHALATION MODE; TIDAL BREATHING MODE; TREATMENT DURATION; AEROSOL; ALGORITHM; BIOLOGICAL MODEL; CLINICAL TRIAL; COMPARATIVE STUDY; DEVICES; DRUG DELIVERY SYSTEM; DRUG EFFECTS; EQUIPMENT DESIGN; GERMANY; INHALATIONAL DRUG ADMINISTRATION; LUNG; METABOLISM; NEBULIZER; PATHOPHYSIOLOGY; PHASE 1 CLINICAL TRIAL; TISSUE DISTRIBUTION; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADULT; AEROSOLS; ALGORITHMS; ALPHA 1-ANTITRYPSIN; ANTI-INFECTIVE AGENTS; ANTI-INFLAMMATORY AGENTS; CROSS-OVER STUDIES; CYSTIC FIBROSIS; DRUG DELIVERY SYSTEMS; EQUIPMENT DESIGN; FEMALE; GERMANY; HUMANS; INHALATION; LUNG; MALE; MODELS, BIOLOGICAL; NEBULIZERS AND VAPORIZERS; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84973352384     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2014.1173     Document Type: Article

References (19)

1. CF-Foundation. Patient Registry 2004 Annual Data Report: Bethesda, Maryland, September 2005.
2. Reynolds HY, Di Sant'Agnese PA, and Zierdt CH: Mucoid Pseudomonas aeruginosa. A sign of cystic fibrosis in young adults with chronic pulmonary disease? JAMA. 1976;236: 2190-2192.
3. Tosi MF, Zakem H, and Berger M: Neutrophil elastase cleaves C3bi on opsonized pseudomonas as well as CR1 on neutrophils to create a functionally important opsonin receptor mismatch. J Clin Invest. 1990;86:300-308.
4. Berger M, Konstan M, Hilliard J, and CF-Prolastin Study Group: Aerosolized prolastin (alpha1-protease inhibitor) in CF. Pediatr Pulmonol. 1995;20:421.
5. Vogelmeier C, Kirlath I, Warrington S, Banik N, Ulbrich E, and Bois RM: The intrapulmonary half-life and safety of aerosolized a1-protease inhibitor in normal volunteers. Am J Respir Crit Care Med. 1997;155:536-541.
6. Kerem E, Bauer S, Strauss P, Jaffe N, Armoni S, Pugatsch T, Shoseyov D, and Tov N: Safety and efficacy of inhaled human alpha-1 antitrypsin (AAT) in cystic fibrosis (CF): A report of a Phase II clinical study. Am J Respir Crit Care Med. 2009;179:A1185.
7. McElvaney NG, Hubbard RC, Birrer P, Chernick MS, Caplan DB, Frank MM, and Crystal RG: Aerosol alpha 1-antitrypsin treatment for cystic fibrosis. Lancet. 1991;337: 392-394.
8. Griese M, Latzin P, Kappler M, Weckerle K, Heinzlmaier T, Bernhardt T, and Hartl D: alpha1-Antitrypsin inhalation reduces airway inflammation in cystic fibrosis patients. Eur Respir J. 2007;29:240-250.
9. Nikander K, Prince I, Coughlin S, Warren S, and Taylor G: Mode of breathing-tidal or slow and deep-through the I-neb Adaptive Aerosol Delivery (AAD) system affects lung deposition of (99m)Tc-DTPA. J Aerosol Med Pulm Drug Deliv. 2010;23:S37-43.
10. Simonian MH: Spectrophotometric determination of protein concentration. Curr Protoc Cell Biol. 2002;Appendix 3:Appendix 3B.
11. Pitcairn GR, and Newman SP: Tissue attenuation corrections in gamma scintigraphy. J Aerosol Med. 1997;10:187-198.
12. Newman S, Bennett WD, Biddiscombe M, Devadason SG, Dolovich MB, Fleming J, Haeussermann S, Kietzig C, Kuehl PJ, Laube BL, Sommerer K, Taylor G, Usmani OS, and Zeman KL: Standardization of techniques for using planar (2D) imaging for aerosol deposition assessment of orally inhaled products. J Aerosol Med Pulm Drug Deliv. 2012;25:S10-28.
13. De Backer W, Devolder A, Poli G, Acerbi D, Monno R, Herpich C, Sommerer K, Meyer T, and Mariotti F: Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2010;23:137-148.
14. Brand P, Meyer T, Weuthen T, Timmer W, Berkel E, Wallenstein G, and Scheuch G: Lung deposition of radiolabeled tiotropium in healthy subjects and patients with chronic obstructive pulmonary disease. J Clin Pharmacol. 2007;47:1335-1341.
15. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, and Wanger J: Standardisation of spirometry. Eur Respir J. 2005;26:319-338.
16. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, and Yernault JC: Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Supp. 1993;16:5-40.
17. Gagnadoux F, Diot P, Marchand S, Thompson R, Dieckman K, Lemarie E, Varaigne F, Maurage C, Baulieu JL, and Rolland JC: [Pulmonary deposition of colistin aerosols in cystic fibrosis. Comparison of an ultrasonic nebulizer and a pneumatic nebulizer]. Rev Mal Respir. 1996;13:55-60.
18. Coates AL, Dinh L, MacNeish CF, Rollin T, Gagnon S, Ho SL, and Lands LC: Accounting for radioactivity before and after nebulization of tobramycin to insure accuracy of quantification of lung deposition. J Aerosol Med. 2000;13:169-178.
19. Coates AL, Green M, Leung K, Louca E, Tservistas M, Chan J, Ribeiro N, and Charron M: The challenges of quantitative measurement of lung deposition using 99mTc-DTPA from delivery systems with very different delivery times. J Aerosol Med. 2007;20:320-330.