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J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.

Collaborators (269)

de Baets F, Desager K, DuPont L, Malfroot A, Albertini M, Belleguic C, Delacourt C, Domblides P, Duhamel JF, Guillot M, Lenoir G, Leroy S, Pautard JC, Remus N, Biedermann T, Hamelmann E, Heuer HE, Mellies U, Schreiber J, Staab D, Steiss JO, Teschler H, Wirtz H, Canny G, Gallagher C, Greally P, Herzig M, Bernasconi S, Colombo C, Gagliardini R, Lucidi V, Pardo F, Pisi G, Quattrucci S, Raia V, Heijerman H, Hendriks J, Amorim A, Barreto C, Antelo C, Asensi JV, Hernandez GG, Maiz L, Peres-Frias F, Boehler A, Moeller A, Carroll M, Conway S, Elborn S, Haworth C, Ketchell I, Taylor C, Walshaw M, Accurso F, Boas S, Chidekel A, Cohen R, Comber P, Daines C, Fink R, Geller D, Graff G, Hadjiliadis D, Hoag J, Liou T, Nakamura C, Naureckas E, Nichols D, Nickerson B, Radford P, Reyes S, Roberts D, Rolfe M, Schmidt H, Sepulveda P, Spencer T, Stone A, Trapnell B, Vauthy P, Virella-Lowell I, Eder J, Eder W, Kovacs K, Langenhorst U, Dewachter E, Dufresne V, Dumonceaux M, Lequesne M, Michils A, Van Bleyenbergh P, Van Daele S, Skov M, Bassinet L, Berlioz M, Brinchault G, Ceccato F, Chedevergne F, Counil F, Desrues B, Gaillot S, Halphen I, Lacroix VB, Laurans M, Mechain-Bui S, Meziane L, Perez T, Picard A, Rames C, Romeo B, Sermet I, Vrielynck S, Wallaert B, Conrad-Kabbe C, Grammann N, Grobe-Onnebrink J, Guttler A, Jobst A, Klahr S, Koerner-Rettberg C, Matena S, Nahrig S, Runge HC, Schwarz C, Sextro W, Tacke A, Weber KC, Wieczorek D, Wolf M, Barry P, Chotirmall S, Elnazir B, Gunaratnam C, Moylett E, Nicolson T, Alghisi F, Cimino G, Cirilli N, Cipolli M, Claut L, Costantini D, Costantino A, De Cristofaro L, De Gregorio F, Di Pierantonio V, Di Stefano V, Faelli N, Longo F, Spicuzza L, Traverso G, Tripodi MC, Troiani P, Vitaliti G, Wesseling GJ, Azeved P, Bento J, Cavaco J, Pereira L, Alvarez MI, Auvilena PC, Barrio I, Codesal MC, Cortina LS, de Valbuena MR, Ferreiro AL, Gonzalez AS, Martinez C, Martinez MT, Perez-Ruiz E, Posadas AS, Urgelles E, Haemmarle K, Hoefer M, Inci D, Spinas R, Aldag I, Barker H, Connett G, Davies J, Etherington C, Floto A, Green B, Gyi KM, Ledson M, Palamarthy A, Perrin F, Rendall J, Wat D, Acton J, Aljadeff G, Allwein L, Amin R, Barnett B, Bartosi S, Biggin M, Boyer D, Brown M, Byars T, Carveth H, Cepeda-Davila E, Chatfield B, Daines M, DeVoogd R, Djekidel K, Donovan C, Dorkin H, Duan L, Ericson D, Federico M, Fornos P, Fuiz F, Goodwin J, Gong G, Grad R, Haddad T, Hadeh A, Heinle R, Herpel L, Hiatt P, Hicks D, Hogarth DK, Holsclaw D, Honsberg A, Jones A, Jones M, Kitch D, Lester L, Lester S, Lewis J, Livingston F, Martin T, Martinez F, Martinez M, Moore M, Mueller G, Narasimhan A, Noth I, O'Hagan A, Onady G, Padman R, Panettieri R, Peeke K, Phillips T, Rhodes D, Rosen J, Royce F, Saavedra M, Sagel S, Clair CS, Sawicki G, Schroeder S, Schulman ES, Schwartz M, Shah A, Sherman M, Smith TC, Sobande P, Stark J, Stenbit A, Strek M, Uluer A, Vender R, Walsh W, Williams R, Woods E, Woodward J, Wooldridge J, Yagi N, Young R, Yuengsrigul A.

Author information

1
Cystic Fibrosis Center, Verona, Italy, Centro Fibrosi Cistica, Azienda Ospedalierouniversitaria di Verona, Piazza Stefani 1, 37100, Verona, Italy. Electronic address: baroukh.assael@ospedaleuniverona.it.
2
National University Hospital, Copenhagen, Denmark.
3
Department of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London England SW3 6NP, United Kingdom.
4
CHU de Bordeaux, Département de Pédiatrie, Centre d'Investigation Clinique (CIC 0005), Hôpital Pellegrin-Enfants, F-33000 Bordeaux, France.
5
Mukoviszidose-Zentrum, Höhenmedizin, Pneumologie, Med. Klinik Innenstadt, Ziemssentr. 1, 80336 Munich, Germany.
6
CHU de Montpellier, Montpellier, France.
7
Dipartimento di Pediatria, Università degli Studi di Catania, Via S. Sofia 78, 95131 Catania, Italy.
8
Hopital Erasme, Brussels, Belgium.
9
Dept of Medicine, RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital, Dublin, Ireland.
10
Gilead Sciences, 199 E. Blaine St., Seattle, WA, 98102, USA.
11
Gilead Sciences, 333 Lakeside Dr., Foster City, CA, 94404, USA.
12
Baylor College of Medicine, Pediatric Pulmonology, TCH Clinical Care Center, 6701 Fannin, Suite 1040.12, Houston, Texas 77030-2399, USA.

Abstract

BACKGROUND:

Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.

METHODS:

273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.

RESULTS:

268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.

CONCLUSIONS:

AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237).

PMID:
22985692
DOI:
10.1016/j.jcf.2012.07.006
[Indexed for MEDLINE]
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