PMID- 28597762
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2045-8932 (Print)
IS  - 2045-8940 (Electronic)
IS  - 2045-8932 (Linking)
VI  - 7
IP  - 2
DP  - 2017 Apr-Jun
TI  - The safety and pharmacokinetics of rapid iloprost aerosol delivery via the 
      BREELIB nebulizer in pulmonary arterial hypertension.
PG  - 505-513
LID - 10.1177/2045893217706691 [doi]
AB  - The BREELIB nebulizer was developed for iloprost to reduce inhalation times for 
      patients with pulmonary arterial hypertension (PAH). This multicenter, 
      randomized, unblinded, four-part study compared inhalation time, 
      pharmacokinetics, and acute tolerability of iloprost 5 microg at mouthpiece delivered 
      via BREELIB versus the standard I-Neb nebulizer in 27 patients with PAH. The 
      primary safety outcome was the proportion of patients with a maximum increase in 
      heart rate (HR) >/= 25% and/or a maximum decrease in systolic blood pressure >/= 20% 
      within 30 min after inhalation. Other safety outcomes included systolic, 
      diastolic, and mean blood pressure, HR, oxygen saturation, and adverse events 
      (AEs). Median inhalation times were considerably shorter with BREELIB versus 
      I-Neb (2.6 versus 10.9 min; n = 24). Maximum iloprost plasma concentration and 
      systemic exposure (area under the plasma concentration-time curve) were 77% and 
      42% higher, respectively, with BREELIB versus I-Neb. Five patients experienced a 
      maximum systolic blood pressure decrease >/= 20%, four with BREELIB (one mildly and 
      transiently symptomatic), and one with I-Neb; none required medical intervention. 
      AEs reported during the study were consistent with the known safety profile of 
      iloprost. The BREELIB nebulizer offers reduced inhalation time, good 
      tolerability, and may improve iloprost aerosol therapy convenience and thus 
      compliance for patients with PAH.
FAU - Gessler, Tobias
AU  - Gessler T
AD  - 1 Department of Internal Medicine II, University of Giessen and Marburg Lung 
      Center and Member of the German Center of Lung Research, Giessen, Germany.
FAU - Ghofrani, Hossein-Ardeschir
AU  - Ghofrani HA
AD  - 1 Department of Internal Medicine II, University of Giessen and Marburg Lung 
      Center and Member of the German Center of Lung Research, Giessen, Germany.
AD  - 2 Department of Medicine, Imperial College London, London, UK.
FAU - Held, Matthias
AU  - Held M
AD  - 3 Respiratory Medicine and Cardiology Section, Department of Internal Medicine, 
      Center for Pulmonary Hypertension and Pulmonary Vascular Disease, Mission Medical 
      Hospital, Wurzburg, Germany.
FAU - Klose, Hans
AU  - Klose H
AD  - 4 Department of Pneumology, University Hospital Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Leuchte, Hanno
AU  - Leuchte H
AD  - 5 Department of Internal Medicine II, Neuwittelsbach Academic Hospital, Ludwig 
      Maximilians University, Munich, Germany.
FAU - Olschewski, Horst
AU  - Olschewski H
AD  - 6 Division of Pulmonology, Medical University of Graz, Graz, Austria.
FAU - Rosenkranz, Stephan
AU  - Rosenkranz S
AD  - 7 Department III of Internal Medicine and Cologne Cardiovascular Research Center, 
      Cologne University Heart Centre, Cologne, Germany.
FAU - Fels, Lueder
AU  - Fels L
AD  - 8 Bayer AG, Berlin, Germany.
FAU - Li, Na
AU  - Li N
AD  - 9 Bayer HealthCare Company Ltd, Beijing, China.
FAU - Ren, Dawn
AU  - Ren D
AD  - 9 Bayer HealthCare Company Ltd, Beijing, China.
FAU - Kaiser, Andreas
AU  - Kaiser A
AD  - 8 Bayer AG, Berlin, Germany.
FAU - Schultze-Mosgau, Marcus-Hillert
AU  - Schultze-Mosgau MH
AD  - 8 Bayer AG, Berlin, Germany.
FAU - Mullinger, Bernhard
AU  - Mullinger B
AD  - 10 Vectura GmbH, Gauting, Germany.
FAU - Rohde, Beate
AU  - Rohde B
AD  - 8 Bayer AG, Berlin, Germany.
FAU - Seeger, Werner
AU  - Seeger W
AD  - 1 Department of Internal Medicine II, University of Giessen and Marburg Lung 
      Center and Member of the German Center of Lung Research, Giessen, Germany.
LA  - eng
PT  - Journal Article
DEP - 20170512
PL  - United States
TA  - Pulm Circ
JT  - Pulmonary circulation
JID - 101557243
PMC - PMC5467944
OTO - NOTNLM
OT  - inhalation time
OT  - patient convenience
OT  - prostacyclin analog
OT  - treatment adherence
EDAT- 2017/06/10 06:00
MHDA- 2017/06/10 06:01
PMCR- 2017/05/12
CRDT- 2017/06/10 06:00
PHST- 2017/06/10 06:00 [entrez]
PHST- 2017/06/10 06:00 [pubmed]
PHST- 2017/06/10 06:01 [medline]
PHST- 2017/05/12 00:00 [pmc-release]
AID - 10.1177_2045893217706691 [pii]
AID - 10.1177/2045893217706691 [doi]
PST - ppublish
SO  - Pulm Circ. 2017 Apr-Jun;7(2):505-513. doi: 10.1177/2045893217706691. Epub 2017 
      May 12.