Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection
Identifieur interne : 000374 ( Main/Merge ); précédent : 000373; suivant : 000375Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection
Auteurs : J P Clancy [États-Unis] ; L. Dupont [Belgique] ; M W Konstan [États-Unis] ; J. Billings [États-Unis] ; S. Fustik ; C H Goss [États-Unis] ; J. Lymp [États-Unis] ; P. Minic [Serbie] ; A L Quittner [États-Unis] ; R C Rubenstein [États-Unis] ; K R Young [États-Unis] ; L. Saiman [États-Unis] ; J L Burns [États-Unis] ; J R W. Govan [Royaume-Uni] ; B. Ramsey [États-Unis] ; R. Gupta [États-Unis] ; J. Clancy ; R. Young ; R. Ahrens ; M. Aitken ; J. Billings ; A. Faro ; C. Goss ; D. Layish ; N. Lechtzin ; M. Light ; S. Miller ; S. Nasr ; J. Nick ; Rc Rubenstein ; A. Sannuti ; G. Sawicki ; J. Taylor-Cousar ; B. Trapnell ; J. Wallace ; P. Minic ; S. Fustik ; E. Solyom ; H. Mazurek ; Y. Antipkin ; A. Feketeova ; A. Senatorova ; E. Csiszer ; V. Kostromina ; B. Takac ; R. Ujhelyi ; A. Sovti ; Anne Marie Buccat ; Catherine DohertySource :
- Thorax [ 0040-6376 ] ; 2013-09.
Abstract
Rationale Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition. Objectives To examine the safety and efficacy of 28 days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa. Methods 105 subjects were evaluated in double-blind, placebo-controlled studies. Subjects were randomised to once-daily Arikace (70, 140, 280 and 560 mg; n=7, 5, 21 and 36 subjects) or placebo (n=36) for 28 days. Primary outcomes included safety and tolerability. Secondary outcomes included lung function (forced expiratory volume at one second (FEV1)), P aeruginosa density in sputum, and the Cystic Fibrosis Quality of Life Questionnaire—Revised (CFQ-R). Results The adverse event profile was similar among Arikace and placebo subjects. The relative change in FEV1 was higher in the 560 mg dose group at day 28 (p=0.033) and at day 56 (28 days post-treatment, 0.093L±0.203 vs −0.032L±0.119; p=0.003) versus placebo. Sputum P aeruginosa density decreased >1 log in the 560 mg group versus placebo (days 14, 28 and 35; p=0.021). The Respiratory Domain of the CFQ-R increased by the Minimal Clinically Important Difference (MCID) in 67% of Arikace subjects (560 mg) versus 36% of placebo (p=0.006), and correlated with FEV1 improvements at days 14, 28 and 42 (p<0.05). An open-label extension (560 mg Arikace) for 28 days followed by 56 days off over six cycles confirmed durable improvements in lung function and sputum P aeruginosa density (n=49). Conclusions Once-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection.
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DOI: 10.1136/thoraxjnl-2012-202230
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Dupont</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Respiratory Medicine, Katholieke Universiteit Leuven, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Konstan, M W" sort="Konstan, M W" uniqKey="Konstan M" first="M W" last="Konstan">M W Konstan</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Billings, J" sort="Billings, J" uniqKey="Billings J" first="J" last="Billings">J. Billings</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pulmonary, Allergy and Critical Care Division, University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Fustik, S" sort="Fustik, S" uniqKey="Fustik S" first="S" last="Fustik">S. Fustik</name><affiliation><wicri:noCountry code="subField">Macedonia</wicri:noCountry></affiliation></author><author><name sortKey="Goss, C H" sort="Goss, C H" uniqKey="Goss C" first="C H" last="Goss">C H Goss</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Washington, Seattle, Washington</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author><author><name sortKey="Lymp, J" sort="Lymp, J" uniqKey="Lymp J" first="J" last="Lymp">J. Lymp</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Seattle Children's Research Institute, Seattle, Washington</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Minic, P" sort="Minic, P" uniqKey="Minic P" first="P" last="Minic">P. Minic</name><affiliation wicri:level="1"><country xml:lang="fr">Serbie</country><wicri:regionArea>Department of Pulmonology, Institute for Mother and Child Healthcare, Belgrade</wicri:regionArea><wicri:noRegion>Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Quittner, A L" sort="Quittner, A L" uniqKey="Quittner A" first="A L" last="Quittner">A L Quittner</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Psychology, University of Miami, Miami, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Rubenstein, R C" sort="Rubenstein, R C" uniqKey="Rubenstein R" first="R C" last="Rubenstein">R C Rubenstein</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Pulmonary Medicine, The Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Young, K R" sort="Young, K R" uniqKey="Young K" first="K R" last="Young">K R Young</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Internal Medicine, Albert Einstein Medical Center, Philadelphia, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Saiman, L" sort="Saiman, L" uniqKey="Saiman L" first="L" last="Saiman">L. Saiman</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, Columbia University, New York, New York</wicri:regionArea><placeName><region type="state">État de New York</region><settlement type="city">New York</settlement></placeName><orgName type="university">Université Columbia</orgName></affiliation></author><author><name sortKey="Burns, J L" sort="Burns, J L" uniqKey="Burns J" first="J L" last="Burns">J L Burns</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Washington, Seattle, Washington</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author><author><name sortKey="Govan, J R W" sort="Govan, J R W" uniqKey="Govan J" first="J R W" last="Govan">J R W. Govan</name><affiliation wicri:level="4"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Medical Microbiology, University of Edinburgh, Edinburgh</wicri:regionArea><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName><orgName type="university">Université d'Édimbourg</orgName></affiliation></author><author><name sortKey="Ramsey, B" sort="Ramsey, B" uniqKey="Ramsey B" first="B" last="Ramsey">B. Ramsey</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Washington, Seattle, Washington</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author><author><name sortKey="Gupta, R" sort="Gupta, R" uniqKey="Gupta R" first="R" last="Gupta">R. Gupta</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Development, Insmed Incorporated, Monmouth Junction, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author wicri:is="80%"><name sortKey="Clancy, J" sort="Clancy, J" uniqKey="Clancy J" first="J" last="Clancy">J. Clancy</name></author><author wicri:is="80%"><name sortKey="Young, R" sort="Young, R" uniqKey="Young R" first="R" last="Young">R. Young</name></author><author wicri:is="80%"><name sortKey="Ahrens, R" sort="Ahrens, R" uniqKey="Ahrens R" first="R" last="Ahrens">R. Ahrens</name></author><author wicri:is="80%"><name sortKey="Aitken, M" sort="Aitken, M" uniqKey="Aitken M" first="M" last="Aitken">M. Aitken</name></author><author wicri:is="80%"><name sortKey="Billings, J" sort="Billings, J" uniqKey="Billings J" first="J" last="Billings">J. Billings</name></author><author wicri:is="80%"><name sortKey="Faro, A" sort="Faro, A" uniqKey="Faro A" first="A" last="Faro">A. Faro</name></author><author wicri:is="80%"><name sortKey="Goss, C" sort="Goss, C" uniqKey="Goss C" first="C" last="Goss">C. Goss</name></author><author wicri:is="80%"><name sortKey="Layish, D" sort="Layish, D" uniqKey="Layish D" first="D" last="Layish">D. Layish</name></author><author wicri:is="80%"><name sortKey="Lechtzin, N" sort="Lechtzin, N" uniqKey="Lechtzin N" first="N" last="Lechtzin">N. Lechtzin</name></author><author wicri:is="80%"><name sortKey="Light, M" sort="Light, M" uniqKey="Light M" first="M" last="Light">M. Light</name></author><author wicri:is="80%"><name sortKey="Miller, S" sort="Miller, S" uniqKey="Miller S" first="S" last="Miller">S. Miller</name></author><author wicri:is="80%"><name sortKey="Nasr, S" sort="Nasr, S" uniqKey="Nasr S" first="S" last="Nasr">S. Nasr</name></author><author wicri:is="80%"><name sortKey="Nick, J" sort="Nick, J" uniqKey="Nick J" first="J" last="Nick">J. Nick</name></author><author wicri:is="80%"><name sortKey="Rubenstein, Rc" sort="Rubenstein, Rc" uniqKey="Rubenstein R" first="Rc" last="Rubenstein">Rc Rubenstein</name></author><author wicri:is="80%"><name sortKey="Sannuti, A" sort="Sannuti, A" uniqKey="Sannuti A" first="A" last="Sannuti">A. Sannuti</name></author><author wicri:is="80%"><name sortKey="Sawicki, G" sort="Sawicki, G" uniqKey="Sawicki G" first="G" last="Sawicki">G. Sawicki</name></author><author wicri:is="80%"><name sortKey="Taylor Cousar, J" sort="Taylor Cousar, J" uniqKey="Taylor Cousar J" first="J" last="Taylor-Cousar">J. Taylor-Cousar</name></author><author wicri:is="80%"><name sortKey="Trapnell, B" sort="Trapnell, B" uniqKey="Trapnell B" first="B" last="Trapnell">B. Trapnell</name></author><author wicri:is="80%"><name sortKey="Wallace, J" sort="Wallace, J" uniqKey="Wallace J" first="J" last="Wallace">J. Wallace</name></author><author wicri:is="80%"><name sortKey="Minic, P" sort="Minic, P" uniqKey="Minic P" first="P" last="Minic">P. Minic</name></author><author wicri:is="80%"><name sortKey="Fustik, S" sort="Fustik, S" uniqKey="Fustik S" first="S" last="Fustik">S. Fustik</name></author><author wicri:is="80%"><name sortKey="Solyom, E" sort="Solyom, E" uniqKey="Solyom E" first="E" last="Solyom">E. Solyom</name></author><author wicri:is="80%"><name sortKey="Mazurek, H" sort="Mazurek, H" uniqKey="Mazurek H" first="H" last="Mazurek">H. Mazurek</name></author><author wicri:is="80%"><name sortKey="Antipkin, Y" sort="Antipkin, Y" uniqKey="Antipkin Y" first="Y" last="Antipkin">Y. Antipkin</name></author><author wicri:is="80%"><name sortKey="Feketeova, A" sort="Feketeova, A" uniqKey="Feketeova A" first="A" last="Feketeova">A. Feketeova</name></author><author wicri:is="80%"><name sortKey="Senatorova, A" sort="Senatorova, A" uniqKey="Senatorova A" first="A" last="Senatorova">A. Senatorova</name></author><author wicri:is="80%"><name sortKey="Csiszer, E" sort="Csiszer, E" uniqKey="Csiszer E" first="E" last="Csiszer">E. Csiszer</name></author><author wicri:is="80%"><name sortKey="Kostromina, V" sort="Kostromina, V" uniqKey="Kostromina V" first="V" last="Kostromina">V. Kostromina</name></author><author wicri:is="80%"><name sortKey="Takac, B" sort="Takac, B" uniqKey="Takac B" first="B" last="Takac">B. Takac</name></author><author wicri:is="80%"><name sortKey="Ujhelyi, R" sort="Ujhelyi, R" uniqKey="Ujhelyi R" first="R" last="Ujhelyi">R. Ujhelyi</name></author><author wicri:is="80%"><name sortKey="Sovti, A" sort="Sovti, A" uniqKey="Sovti A" first="A" last="Sovti">A. Sovti</name></author><author wicri:is="80%"><name sortKey="Buccat, Anne Marie" sort="Buccat, Anne Marie" uniqKey="Buccat A" first="Anne Marie" last="Buccat">Anne Marie Buccat</name></author><author wicri:is="80%"><name sortKey="Doherty, Catherine" sort="Doherty, Catherine" uniqKey="Doherty C" first="Catherine" last="Doherty">Catherine Doherty</name></author></analytic><monogr></monogr><series><title level="j">Thorax</title><title level="j" type="abbrev">Thorax</title><idno type="ISSN">0040-6376</idno><idno type="eISSN">1468-3296</idno><imprint><publisher>BMJ Publishing Group Ltd and British Thoracic Society</publisher><date type="published" when="2013-09">2013-09</date><biblScope unit="volume">68</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="818">818</biblScope></imprint><idno type="ISSN">0040-6376</idno></series><idno type="istex">D6E59547A98757F5A3D798E74EB2093A15AA6978</idno><idno type="DOI">10.1136/thoraxjnl-2012-202230</idno><idno type="href">thoraxjnl-68-818.pdf</idno><idno type="ArticleID">thoraxjnl-2012-202230</idno><idno type="PMID">23749840</idno><idno type="local">thoraxjnl;68/9/818</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0040-6376</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Rationale Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition. Objectives To examine the safety and efficacy of 28 days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa. Methods 105 subjects were evaluated in double-blind, placebo-controlled studies. Subjects were randomised to once-daily Arikace (70, 140, 280 and 560 mg; n=7, 5, 21 and 36 subjects) or placebo (n=36) for 28 days. Primary outcomes included safety and tolerability. Secondary outcomes included lung function (forced expiratory volume at one second (FEV1)), P aeruginosa density in sputum, and the Cystic Fibrosis Quality of Life Questionnaire—Revised (CFQ-R). Results The adverse event profile was similar among Arikace and placebo subjects. The relative change in FEV1 was higher in the 560 mg dose group at day 28 (p=0.033) and at day 56 (28 days post-treatment, 0.093L±0.203 vs −0.032L±0.119; p=0.003) versus placebo. Sputum P aeruginosa density decreased >1 log in the 560 mg group versus placebo (days 14, 28 and 35; p=0.021). The Respiratory Domain of the CFQ-R increased by the Minimal Clinically Important Difference (MCID) in 67% of Arikace subjects (560 mg) versus 36% of placebo (p=0.006), and correlated with FEV1 improvements at days 14, 28 and 42 (p<0.05). An open-label extension (560 mg Arikace) for 28 days followed by 56 days off over six cycles confirmed durable improvements in lung function and sputum P aeruginosa density (n=49). Conclusions Once-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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