title: Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.
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).
authors.affiliation: Cystic Fibrosis Center, Verona, Italy, Centro Fibrosi Cistica, Azienda Ospedalierouniversitaria di Verona, Piazza Stefani 1, 37100, Verona, Italy. Electronic address: baroukh.assael@ospedaleuniverona.it.
authors.forename: Baroukh M
authors.initials: BM
authors.lastname: Assael
authors.affiliation: National University Hospital, Copenhagen, Denmark.
authors.forename: Tacjana
authors.initials: T
authors.lastname: Pressler
authors.affiliation: Department of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London England SW3 6NP, United Kingdom.
authors.forename: Diana
authors.initials: D
authors.lastname: Bilton
authors.affiliation: CHU de Bordeaux, Département de Pédiatrie, Centre d'Investigation Clinique (CIC 0005), Hôpital Pellegrin-Enfants, F-33000 Bordeaux, France.
authors.forename: Michael
authors.initials: M
authors.lastname: Fayon
authors.affiliation: Mukoviszidose-Zentrum, Höhenmedizin, Pneumologie, Med. Klinik Innenstadt, Ziemssentr. 1, 80336 Munich, Germany.
authors.forename: Rainald
authors.initials: R
authors.lastname: Fischer
authors.affiliation: CHU de Montpellier, Montpellier, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Chiron
authors.affiliation: Dipartimento di Pediatria, Università degli Studi di Catania, Via S. Sofia 78, 95131 Catania, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: LaRosa
authors.affiliation: Hopital Erasme, Brussels, Belgium.
authors.forename: Christiane
authors.initials: C
authors.lastname: Knoop
authors.affiliation: Dept of Medicine, RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital, Dublin, Ireland.
authors.forename: Noel
authors.initials: N
authors.lastname: McElvaney
authors.affiliation: Gilead Sciences, 199 E. Blaine St., Seattle, WA, 98102, USA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Lewis
authors.affiliation: Gilead Sciences, 333 Lakeside Dr., Foster City, CA, 94404, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Bresnik
authors.affiliation: Gilead Sciences, 199 E. Blaine St., Seattle, WA, 98102, USA.
authors.forename: A Bruce
authors.initials: AB
authors.lastname: Montgomery
authors.affiliation: Baylor College of Medicine, Pediatric Pulmonology, TCH Clinical Care Center, 6701 Fannin, Suite 1040.12, Houston, Texas 77030-2399, USA.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Oermann
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001398:Aztreonam / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D003550:Cystic Fibrosis / Q000382:microbiology* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D011552:Pseudomonas Infections / Q000188:drug therapy*; D012129:Respiratory Function Tests; D014031:Tobramycin / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D001398:Aztreonam; D014031:Tobramycin