Pharmacokinetics and Tolerability of Once Daily Double Dose Tobramycin Inhalation in Cystic Fibrosis Using Controlled and Conventional Nebulization
Better treatment outcomes in cystic fibrosis (CF) may be expected by changing standard twice daily (BID) tobramycin inhalation with the conventional nebulizer to once daily (OD) inhalation at double the standard BID dose with a controlled-inhalation nebulizer. We aimed to determine the pharmacokinet...
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| Veröffentlicht in: | Journal of aerosol medicine 2016-06, Vol.29 (3), p.273-280 |
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| creator | van Velzen, A J Bos, A C Touw, D J Tiddens, H A W M Heijerman, H G M Janssens, H M |
| description | Better treatment outcomes in cystic fibrosis (CF) may be expected by changing standard twice daily (BID) tobramycin inhalation with the conventional nebulizer to once daily (OD) inhalation at double the standard BID dose with a controlled-inhalation nebulizer. We aimed to determine the pharmacokinetics and tolerability of inhaled double-dose tobramycin with the controlled-inhalation AKITA(®) and conventional PARI-LC(®) Plus nebulizer in patients with CF.
Randomized, open label, crossover study. Pharmacokinetics were assessed in 10 adult CF patients following inhalation of tobramycin (Bramitob(®)) at double the recommended BID dose with the AKITA (300 mg fill dose) and PARI-LC Plus (600 mg fill dose).
No significant differences were found in pharmacokinetic parameters between the two nebulizers. Median maximum serum levels were 3.44 (2.25-5.49) and 2.84 (0.82-6.63) mg/L for AKITA and PARI-LC Plus, respectively. Trough serum levels were very low for both nebulizers: 0.03 (0.00-0.09) and 0.02 (0.00-0.06) mg/L for AKITA and PARI-LC Plus, respectively. Time to maximum level was comparable: 0.44 (0.08-0.96) and 0.40 (0.08-0.96) hours for AKITA and PARI-LC Plus, respectively. Serum levels were well below the toxic limit. Inhalations were well tolerated and no serious adverse events occurred. Nebulization time was 33% shorter with the AKITA.
OD tobramycin inhalation of the double standard BID dose with a controlled-inhalation and conventional nebulizer resulted in similar pharmacokinetics in the doses given, with serum levels below the toxic limit. Further research demonstrating clinical efficacy and safety of this treatment approach is required. Dutch trial register number NTR4525. |
| doi_str_mv | 10.1089/jamp.2015.1259 |
| format | Article |
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Randomized, open label, crossover study. Pharmacokinetics were assessed in 10 adult CF patients following inhalation of tobramycin (Bramitob(®)) at double the recommended BID dose with the AKITA (300 mg fill dose) and PARI-LC Plus (600 mg fill dose).
No significant differences were found in pharmacokinetic parameters between the two nebulizers. Median maximum serum levels were 3.44 (2.25-5.49) and 2.84 (0.82-6.63) mg/L for AKITA and PARI-LC Plus, respectively. Trough serum levels were very low for both nebulizers: 0.03 (0.00-0.09) and 0.02 (0.00-0.06) mg/L for AKITA and PARI-LC Plus, respectively. Time to maximum level was comparable: 0.44 (0.08-0.96) and 0.40 (0.08-0.96) hours for AKITA and PARI-LC Plus, respectively. Serum levels were well below the toxic limit. Inhalations were well tolerated and no serious adverse events occurred. Nebulization time was 33% shorter with the AKITA.
OD tobramycin inhalation of the double standard BID dose with a controlled-inhalation and conventional nebulizer resulted in similar pharmacokinetics in the doses given, with serum levels below the toxic limit. Further research demonstrating clinical efficacy and safety of this treatment approach is required. Dutch trial register number NTR4525.</description><identifier>ISSN: 1941-2711</identifier><identifier>EISSN: 1941-2703</identifier><identifier>DOI: 10.1089/jamp.2015.1259</identifier><identifier>PMID: 26716357</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Administration, Inhalation ; Adult ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - blood ; Anti-Bacterial Agents - pharmacokinetics ; Cross-Over Studies ; Cystic Fibrosis - blood ; Cystic Fibrosis - diagnosis ; Cystic Fibrosis - drug therapy ; Cystic Fibrosis - physiopathology ; Drug Administration Schedule ; Drug Monitoring ; Female ; Humans ; Lung - physiopathology ; Male ; Middle Aged ; Nebulizers and Vaporizers ; Netherlands ; Patient Satisfaction ; Tobramycin - administration & dosage ; Tobramycin - adverse effects ; Tobramycin - blood ; Tobramycin - pharmacokinetics ; Treatment Outcome ; Young Adult</subject><ispartof>Journal of aerosol medicine, 2016-06, Vol.29 (3), p.273-280</ispartof><rights>(©) Copyright 2015, Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-515e3c0f6dca87b3498b6b449da3f8982895125ae57b1c87c5322aa846bffba93</citedby><cites>FETCH-LOGICAL-c396t-515e3c0f6dca87b3498b6b449da3f8982895125ae57b1c87c5322aa846bffba93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27933,27934</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26716357$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Velzen, A J</creatorcontrib><creatorcontrib>Bos, A C</creatorcontrib><creatorcontrib>Touw, D J</creatorcontrib><creatorcontrib>Tiddens, H A W M</creatorcontrib><creatorcontrib>Heijerman, H G M</creatorcontrib><creatorcontrib>Janssens, H M</creatorcontrib><title>Pharmacokinetics and Tolerability of Once Daily Double Dose Tobramycin Inhalation in Cystic Fibrosis Using Controlled and Conventional Nebulization</title><title>Journal of aerosol medicine</title><addtitle>J Aerosol Med Pulm Drug Deliv</addtitle><description>Better treatment outcomes in cystic fibrosis (CF) may be expected by changing standard twice daily (BID) tobramycin inhalation with the conventional nebulizer to once daily (OD) inhalation at double the standard BID dose with a controlled-inhalation nebulizer. We aimed to determine the pharmacokinetics and tolerability of inhaled double-dose tobramycin with the controlled-inhalation AKITA(®) and conventional PARI-LC(®) Plus nebulizer in patients with CF.
Randomized, open label, crossover study. Pharmacokinetics were assessed in 10 adult CF patients following inhalation of tobramycin (Bramitob(®)) at double the recommended BID dose with the AKITA (300 mg fill dose) and PARI-LC Plus (600 mg fill dose).
No significant differences were found in pharmacokinetic parameters between the two nebulizers. Median maximum serum levels were 3.44 (2.25-5.49) and 2.84 (0.82-6.63) mg/L for AKITA and PARI-LC Plus, respectively. Trough serum levels were very low for both nebulizers: 0.03 (0.00-0.09) and 0.02 (0.00-0.06) mg/L for AKITA and PARI-LC Plus, respectively. Time to maximum level was comparable: 0.44 (0.08-0.96) and 0.40 (0.08-0.96) hours for AKITA and PARI-LC Plus, respectively. Serum levels were well below the toxic limit. Inhalations were well tolerated and no serious adverse events occurred. Nebulization time was 33% shorter with the AKITA.
OD tobramycin inhalation of the double standard BID dose with a controlled-inhalation and conventional nebulizer resulted in similar pharmacokinetics in the doses given, with serum levels below the toxic limit. Further research demonstrating clinical efficacy and safety of this treatment approach is required. Dutch trial register number NTR4525.</description><subject>Administration, Inhalation</subject><subject>Adult</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - blood</subject><subject>Anti-Bacterial Agents - pharmacokinetics</subject><subject>Cross-Over Studies</subject><subject>Cystic Fibrosis - blood</subject><subject>Cystic Fibrosis - diagnosis</subject><subject>Cystic Fibrosis - drug therapy</subject><subject>Cystic Fibrosis - physiopathology</subject><subject>Drug Administration Schedule</subject><subject>Drug Monitoring</subject><subject>Female</subject><subject>Humans</subject><subject>Lung - physiopathology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nebulizers and Vaporizers</subject><subject>Netherlands</subject><subject>Patient Satisfaction</subject><subject>Tobramycin - administration & dosage</subject><subject>Tobramycin - adverse effects</subject><subject>Tobramycin - blood</subject><subject>Tobramycin - pharmacokinetics</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1941-2711</issn><issn>1941-2703</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNpdkc1u1DAUhS0EoqWwZYkssWEzgx3Hf0s0paVSRVm06-jacagHxx7spFJ4DV64Tlu6YGUf6bvHPx9C7ynZUqL05z2Mh21DKN_ShusX6Jjqlm4aSdjL5z2lR-hNKXtCBG0Fe42OGiGpYFweo78_biGPYNMvH93kbcEQe3ydgstgfPDTgtOAr6J1-BR8WPBpmk2oIRVXMZNhXKyP-CLeQoDJp4hr2i2lduEzb3IqvuCb4uNPvEtxyikE1z8cUuOdi-sIBPzdmTn4Pw8Nb9GrAUJx757WE3Rz9vV6921zeXV-sftyubFMi2nDKXfMkkH0FpQ0rNXKCNO2ugc2KK0apXn9FHBcGmqVtJw1DYBqhRkGA5qdoE-PvYecfs-uTN3oi3UhQHRpLh1VUiomhFYV_fgfuk9zrhevlNSaa6JaWqntI2Xrs0t2Q3fIfoS8dJR0q65u1dWturpVVx348FQ7m9H1z_g_P-weaX-TIw</recordid><startdate>201606</startdate><enddate>201606</enddate><creator>van Velzen, A J</creator><creator>Bos, A C</creator><creator>Touw, D J</creator><creator>Tiddens, H A W M</creator><creator>Heijerman, H G M</creator><creator>Janssens, H M</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>201606</creationdate><title>Pharmacokinetics and Tolerability of Once Daily Double Dose Tobramycin Inhalation in Cystic Fibrosis Using Controlled and Conventional Nebulization</title><author>van Velzen, A J ; Bos, A C ; Touw, D J ; Tiddens, H A W M ; Heijerman, H G M ; Janssens, H M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-515e3c0f6dca87b3498b6b449da3f8982895125ae57b1c87c5322aa846bffba93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Inhalation</topic><topic>Adult</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Anti-Bacterial Agents - blood</topic><topic>Anti-Bacterial Agents - pharmacokinetics</topic><topic>Cross-Over Studies</topic><topic>Cystic Fibrosis - blood</topic><topic>Cystic Fibrosis - diagnosis</topic><topic>Cystic Fibrosis - drug therapy</topic><topic>Cystic Fibrosis - physiopathology</topic><topic>Drug Administration Schedule</topic><topic>Drug Monitoring</topic><topic>Female</topic><topic>Humans</topic><topic>Lung - physiopathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nebulizers and Vaporizers</topic><topic>Netherlands</topic><topic>Patient Satisfaction</topic><topic>Tobramycin - administration & dosage</topic><topic>Tobramycin - adverse effects</topic><topic>Tobramycin - blood</topic><topic>Tobramycin - pharmacokinetics</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Velzen, A J</creatorcontrib><creatorcontrib>Bos, A C</creatorcontrib><creatorcontrib>Touw, D J</creatorcontrib><creatorcontrib>Tiddens, H A W M</creatorcontrib><creatorcontrib>Heijerman, H G M</creatorcontrib><creatorcontrib>Janssens, H M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of aerosol medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Velzen, A J</au><au>Bos, A C</au><au>Touw, D J</au><au>Tiddens, H A W M</au><au>Heijerman, H G M</au><au>Janssens, H M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics and Tolerability of Once Daily Double Dose Tobramycin Inhalation in Cystic Fibrosis Using Controlled and Conventional Nebulization</atitle><jtitle>Journal of aerosol medicine</jtitle><addtitle>J Aerosol Med Pulm Drug Deliv</addtitle><date>2016-06</date><risdate>2016</risdate><volume>29</volume><issue>3</issue><spage>273</spage><epage>280</epage><pages>273-280</pages><issn>1941-2711</issn><eissn>1941-2703</eissn><abstract>Better treatment outcomes in cystic fibrosis (CF) may be expected by changing standard twice daily (BID) tobramycin inhalation with the conventional nebulizer to once daily (OD) inhalation at double the standard BID dose with a controlled-inhalation nebulizer. We aimed to determine the pharmacokinetics and tolerability of inhaled double-dose tobramycin with the controlled-inhalation AKITA(®) and conventional PARI-LC(®) Plus nebulizer in patients with CF.
Randomized, open label, crossover study. Pharmacokinetics were assessed in 10 adult CF patients following inhalation of tobramycin (Bramitob(®)) at double the recommended BID dose with the AKITA (300 mg fill dose) and PARI-LC Plus (600 mg fill dose).
No significant differences were found in pharmacokinetic parameters between the two nebulizers. Median maximum serum levels were 3.44 (2.25-5.49) and 2.84 (0.82-6.63) mg/L for AKITA and PARI-LC Plus, respectively. Trough serum levels were very low for both nebulizers: 0.03 (0.00-0.09) and 0.02 (0.00-0.06) mg/L for AKITA and PARI-LC Plus, respectively. Time to maximum level was comparable: 0.44 (0.08-0.96) and 0.40 (0.08-0.96) hours for AKITA and PARI-LC Plus, respectively. Serum levels were well below the toxic limit. Inhalations were well tolerated and no serious adverse events occurred. Nebulization time was 33% shorter with the AKITA.
OD tobramycin inhalation of the double standard BID dose with a controlled-inhalation and conventional nebulizer resulted in similar pharmacokinetics in the doses given, with serum levels below the toxic limit. Further research demonstrating clinical efficacy and safety of this treatment approach is required. Dutch trial register number NTR4525.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>26716357</pmid><doi>10.1089/jamp.2015.1259</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1941-2711 |
| ispartof | Journal of aerosol medicine, 2016-06, Vol.29 (3), p.273-280 |
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| subjects | Administration, Inhalation Adult Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - blood Anti-Bacterial Agents - pharmacokinetics Cross-Over Studies Cystic Fibrosis - blood Cystic Fibrosis - diagnosis Cystic Fibrosis - drug therapy Cystic Fibrosis - physiopathology Drug Administration Schedule Drug Monitoring Female Humans Lung - physiopathology Male Middle Aged Nebulizers and Vaporizers Netherlands Patient Satisfaction Tobramycin - administration & dosage Tobramycin - adverse effects Tobramycin - blood Tobramycin - pharmacokinetics Treatment Outcome Young Adult |
| title | Pharmacokinetics and Tolerability of Once Daily Double Dose Tobramycin Inhalation in Cystic Fibrosis Using Controlled and Conventional Nebulization |
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