Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection
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....
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| Vydáno v: | Thorax Ročník 68; číslo 9; s. 818 - 825 |
|---|---|
| Hlavní autoři: | , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
England
BMJ Publishing Group Ltd and British Thoracic Society
01.09.2013
BMJ Publishing Group LTD BMJ Publishing Group |
| Edice: | Original article |
| Témata: | |
| ISSN: | 0040-6376, 1468-3296, 1468-3296 |
| On-line přístup: | Získat plný text |
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| 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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| AbstractList | 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. RationaleArikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition.ObjectivesTo examine the safety and efficacy of 28days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa.Methods105 subjects were evaluated in double-blind, placebo-controlled studies. Subjects were randomised to once-daily Arikace (70, 140, 280 and 560mg; n=7, 5, 21 and 36 subjects) or placebo (n=36) for 28days. 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).ResultsThe adverse event profile was similar among Arikace and placebo subjects. The relative change in FEV1 was higher in the 560mg dose group at day 28 (p=0.033) and at day 56 (28days post-treatment, 0.093L plus or minus 0.203 vs -0.032L plus or minus 0.119; p=0.003) versus placebo. Sputum P aeruginosa density decreased >1 log in the 560mg 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 (560mg) 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 (560mg Arikace) for 28days followed by 56days off over six cycles confirmed durable improvements in lung function and sputum P aeruginosa density (n=49).ConclusionsOnce-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection. Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition.RATIONALEArikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition.To examine the safety and efficacy of 28 days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa.OBJECTIVESTo examine the safety and efficacy of 28 days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa.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).METHODS105 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).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).RESULTSThe 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).Once-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection.CONCLUSIONSOnce-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection. 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. Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition. To examine the safety and efficacy of 28 days of once-daily Arikace in cystic fibrosis (CF) patients chronically infected with P aeruginosa. 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). 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). Once-daily Arikace demonstrated acute tolerability, safety, biologic activity and efficacy in patients with CF with P aeruginosa infection. |
| Author | Lymp, J Minic, P Saiman, L Govan, J R W Billings, J Ramsey, B Goss, C H Konstan, M W Quittner, A L Gupta, R Fustik, S Young, K R Dupont, L Burns, J L Clancy, J P Rubenstein, R C |
| AuthorAffiliation | 5 Department of Pediatrics , University Clinical Centre , Skopje , Macedonia 6 Department of Medicine , University of Washington , Seattle, Washington , USA 9 Department of Psychology , University of Miami , Miami, Florida , USA 13 Department of Medical Microbiology , University of Edinburgh , Edinburgh , UK 4 Pulmonary, Allergy and Critical Care Division , University of Minnesota , Minneapolis, Minnesota , USA 12 Department of Pediatrics , Columbia University , New York, New York , USA 7 Seattle Children's Research Institute , Seattle, Washington , USA 11 Department of Internal Medicine, Albert Einstein Medical Center , Philadelphia, Pennsylvania , USA 2 Department of Respiratory Medicine, Katholieke Universiteit Leuven , Leuven , Belgium 8 Department of Pulmonology , Institute for Mother and Child Healthcare , Belgrade , Serbia 14 Department of Development , Insmed Incorporated , Monmouth Junction, New Jersey , USA 10 Division of Pulmonary Medicine , The Children's Hospital of Philadelphia and |
| AuthorAffiliation_xml | – name: 3 Department of Pediatrics, Case Western Reserve University , Cleveland, Ohio , USA – name: 2 Department of Respiratory Medicine, Katholieke Universiteit Leuven , Leuven , Belgium – name: 8 Department of Pulmonology , Institute for Mother and Child Healthcare , Belgrade , Serbia – name: 1 Department of Pediatrics, Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio , USA – name: 14 Department of Development , Insmed Incorporated , Monmouth Junction, New Jersey , USA – name: 11 Department of Internal Medicine, Albert Einstein Medical Center , Philadelphia, Pennsylvania , USA – name: 9 Department of Psychology , University of Miami , Miami, Florida , USA – name: 6 Department of Medicine , University of Washington , Seattle, Washington , USA – name: 12 Department of Pediatrics , Columbia University , New York, New York , USA – name: 13 Department of Medical Microbiology , University of Edinburgh , Edinburgh , UK – name: 4 Pulmonary, Allergy and Critical Care Division , University of Minnesota , Minneapolis, Minnesota , USA – name: 5 Department of Pediatrics , University Clinical Centre , Skopje , Macedonia – name: 10 Division of Pulmonary Medicine , The Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania , Philadelphia, Pennsylvania , USA – name: 7 Seattle Children's Research Institute , Seattle, Washington , USA |
| Author_xml | – sequence: 1 givenname: J P surname: Clancy fullname: Clancy, J P email: john.clancy@cchmc.org organization: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA – sequence: 2 givenname: L surname: Dupont fullname: Dupont, L email: john.clancy@cchmc.org organization: Department of Respiratory Medicine, Katholieke Universiteit Leuven, Leuven, Belgium – sequence: 3 givenname: M W surname: Konstan fullname: Konstan, M W email: john.clancy@cchmc.org organization: Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio, USA – sequence: 4 givenname: J surname: Billings fullname: Billings, J email: john.clancy@cchmc.org organization: Pulmonary, Allergy and Critical Care Division, University of Minnesota, Minneapolis, Minnesota, USA – sequence: 5 givenname: S surname: Fustik fullname: Fustik, S email: john.clancy@cchmc.org organization: Department of Pediatrics, University Clinical Centre, Skopje, Macedonia – sequence: 6 givenname: C H surname: Goss fullname: Goss, C H email: john.clancy@cchmc.org organization: Department of Medicine, University of Washington, Seattle, Washington, USA – sequence: 7 givenname: J surname: Lymp fullname: Lymp, J email: john.clancy@cchmc.org organization: Seattle Children's Research Institute, Seattle, Washington, USA – sequence: 8 givenname: P surname: Minic fullname: Minic, P email: john.clancy@cchmc.org organization: Department of Pulmonology, Institute for Mother and Child Healthcare, Belgrade, Serbia – sequence: 9 givenname: A L surname: Quittner fullname: Quittner, A L email: john.clancy@cchmc.org organization: Department of Psychology, University of Miami, Miami, Florida, USA – sequence: 10 givenname: R C surname: Rubenstein fullname: Rubenstein, R C email: john.clancy@cchmc.org organization: Division of Pulmonary Medicine, The Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA – sequence: 11 givenname: K R surname: Young fullname: Young, K R email: john.clancy@cchmc.org organization: Department of Internal Medicine, Albert Einstein Medical Center, Philadelphia, Pennsylvania, USA – sequence: 12 givenname: L surname: Saiman fullname: Saiman, L email: john.clancy@cchmc.org organization: Department of Pediatrics, Columbia University, New York, New York, USA – sequence: 13 givenname: J L surname: Burns fullname: Burns, J L email: john.clancy@cchmc.org organization: Department of Medicine, University of Washington, Seattle, Washington, USA – sequence: 14 givenname: J R W surname: Govan fullname: Govan, J R W email: john.clancy@cchmc.org organization: Department of Medical Microbiology, University of Edinburgh, Edinburgh, UK – sequence: 15 givenname: B surname: Ramsey fullname: Ramsey, B email: john.clancy@cchmc.org organization: Department of Medicine, University of Washington, Seattle, Washington, USA – sequence: 16 givenname: R surname: Gupta fullname: Gupta, R email: john.clancy@cchmc.org organization: Department of Development, Insmed Incorporated, Monmouth Junction, New Jersey, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23749840$$D View this record in MEDLINE/PubMed |
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| Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2013 |
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| Keywords | Cystic Fibrosis Bacterial Infection Respiratory Infection |
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| Notes | href:thoraxjnl-68-818.pdf local:thoraxjnl;68/9/818 istex:D6E59547A98757F5A3D798E74EB2093A15AA6978 ArticleID:thoraxjnl-2012-202230 JPC and LD contributed equally. ark:/67375/NVC-Q73PX3TS-0 PMID:23749840 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 The Altera Nebulizer System is a registered trademark of PARI Respiratory Equipment (2943 Oak Lake Blvd, Midlothian, VA 23112, USA). |
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| Snippet | Rationale Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition. Objectives... Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition. To examine the... Arikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition.RATIONALEArikace is a... RationaleArikace is a liposomal amikacin preparation for aerosol delivery with potent Pseudomonas aeruginosa killing and prolonged lung deposition.ObjectivesTo... |
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| SubjectTerms | Adolescent Adult Amikacin - administration & dosage Amikacin - adverse effects Analysis of Variance Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Antibiotics Bacterial Infection Child Cystic Fibrosis Cystic Fibrosis - complications Cystic Fibrosis - physiopathology Double-Blind Method Drug dosages FDA approval Female Forced Expiratory Volume Humans Infections Liposomes Male Microbial Sensitivity Tests Mortality Mutation Nebulizers and Vaporizers Patients Pharmacokinetics Pseudomonas aeruginosa Pseudomonas Infections - drug therapy Quality of Life Respiratory Infection Sputum - microbiology Young Adult |
| Title | Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection |
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