PMID- 27435882
OWN - NLM
STAT- MEDLINE
DCOM- 20170928
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 32
IP  - 11
DP  - 2016 Nov
TI  - Long-term safety of tobramycin inhalation powder in patients with cystic 
      fibrosis: phase IV (ETOILES) study.
PG  - 1789-1795
AB  - OBJECTIVE: Long-term treatment with inhaled antibiotics is recommended for 
      chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) patients. 
      The ETOILES study (Clinicaltrials.gov identifier: NCT01519661) evaluated the 
      safety of tobramycin inhalation powder (TIP) for 1 year. RESEARCH DESIGN AND 
      METHODS: This single-arm, open-label, multicenter, phase IV trial, enrolled CF 
      patients aged >/=6 years, with baseline FEV(1) >/=25%-</=75% predicted and Pa 
      infection, and assessed the safety of TIP over six cycles in terms of the 
      incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs). 
      Secondary endpoints included presence of airway reactivity, relative change in 
      FEV(1)% predicted, and change in sputum Pa density (log(10) colony forming 
      units/g sputum). RESULTS: A total of 157 patients were enrolled, and 96 patients 
      (61.1%) completed the study. The most commonly reported AE was infective 
      pulmonary exacerbation of CF (55.4%). Cough was reported as an AE in 23.6% of 
      patients; a majority were mild or moderate and two were severe (1.3%). SAEs were 
      reported by 31.2% of patients. No deaths were reported during the study. There 
      were no clinically meaningful changes reported in airway reactivity. Most 
      frequently reported post-inhalation event was cough at all time points; however, 
      it was of short duration (<4 minutes) and decreased over the course of the study, 
      possibly due to patients becoming more experienced with the administration of 
      TIP. The post-inhalation events resolved without intervention in most cases. 
      FEV(1)% predicted remained stable from Cycles 1 to 4 and tended to decrease 
      thereafter, although it was not statistically significant (change from baseline 
      to study end mean [SD] = -1.9% [14.55]; P = 0.199). CONCLUSIONS: This was one of 
      the largest studies with long-term TIP exposure. The majority of patients 
      enrolled were adults with more advanced CF lung disease than those in previous 
      TIP studies. No new emerging safety signals were seen and efficacy was sustained 
      during the year.
FAU - Sommerwerck, Urte
AU  - Sommerwerck U
AD  - a Department of Pneumology , Ruhrlandklinik, West German Lung Centre, University 
      Hospital Essen , Essen , Germany.
AD  - b Christiane Herzog Center Ruhr , Essen/Bochum , Germany.
FAU - Virella-Lowell, Isabel
AU  - Virella-Lowell I
AD  - c Department of Pediatrics , Medical University of South Carolina, Pediatric 
      Pulmonology and Sleep Medicine , Charleston , SC , USA.
FAU - Angyalosi, Gerhild
AU  - Angyalosi G
AD  - d Novartis Pharma AG , Basel , Switzerland.
FAU - Viegas, Andrea
AU  - Viegas A
AD  - e Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
FAU - Cao, Weihua
AU  - Cao W
AD  - e Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
FAU - Debonnett, Laurie
AU  - Debonnett L
AD  - e Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01519661
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160909
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Powders)
RN  - VZ8RRZ51VK (Tobramycin)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/*adverse effects
MH  - Cough/chemically induced
MH  - Cystic Fibrosis/*complications/physiopathology
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Male
MH  - Powders
MH  - Pseudomonas Infections/*drug therapy
MH  - *Pseudomonas aeruginosa
MH  - Tobramycin/administration & dosage/*adverse effects
OTO - NOTNLM
OT  - Cystic fibrosis
OT  - Dry powder inhaler (DPI)
OT  - Pseudomonas aeruginosa
OT  - Safety
OT  - Tobramycin
EDAT- 2016/10/19 06:00
MHDA- 2017/09/29 06:00
CRDT- 2016/07/21 06:00
PHST- 2016/10/19 06:00 [pubmed]
PHST- 2017/09/29 06:00 [medline]
PHST- 2016/07/21 06:00 [entrez]
AID - 10.1080/03007995.2016.1211516 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2016 Nov;32(11):1789-1795. doi: 10.1080/03007995.2016.1211516. 
      Epub 2016 Sep 9.