scholarly journals ePS3.09 The effect of chest physiotherapy with the Simeox airway clearance technology in the treatment of cystic fibrosis pulmonary exacerbation - open-label study

2019 ◽  
Vol 18 ◽  
pp. S46-S47
Author(s):  
K. Walicka-Serzysko ◽  
M. Postek ◽  
N. Jeneralska ◽  
A. Cichocka ◽  
J. Milczewska ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Chest Physiotherapy ◽  
Pulmonary Exacerbation ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Airway Clearance ◽  
Cystic Fibrosis Pulmonary Exacerbation

scholarly journals 55 Lumacaftor/ivacaftor (LUM/IVA) in patients (pts) with cystic fibrosis (CF) and advanced lung disease homozygous for F508del-CFTR: a 24-week open-label study

2017 ◽  
Vol 16 ◽  
pp. S78 ◽  
Author(s):  
J. Taylor-Cousar ◽  
M. Jain ◽  
T.L. Barto ◽  
T. Haddad ◽  
J. Atkinson ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Lung Disease ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals WS7.5 Interim results of the phase 3 open-label study of ataluren in nonsense mutation cystic fibrosis (nmCF)

2013 ◽  
Vol 12 ◽  
pp. S15 ◽  
Author(s):  
E. Kerem ◽  
M. Wilschanski ◽  
I. Sermet-Gaudelus ◽  
K. De Boeck ◽  
F.J. Accurso ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Nonsense Mutation ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study

scholarly journals Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study

2015 ◽  
Vol 14 (1) ◽  
pp. 111-119 ◽  
Author(s):  
H.A.W.M. Tiddens ◽  
K. De Boeck ◽  
J.P. Clancy ◽  
M. Fayon ◽  
Arets H.G.M. ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Population Pharmacokinetics and Safety of Ceftolozane-Tazobactam in Adult Cystic Fibrosis Patients Admitted with Acute Pulmonary Exacerbation

2016 ◽  
Vol 60 (11) ◽  
pp. 6578-6584 ◽  
Author(s):  
Marguerite L. Monogue ◽  
Rebecca S. Pettit ◽  
Marianne Muhlebach ◽  
Jeffrey J. Cies ◽  
David P. Nicolau ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Pseudomonas Aeruginosa ◽  
Population Pharmacokinetics ◽  
Central Compartment ◽  
Pulmonary Exacerbation ◽  
Target Attainment ◽  
Open Label ◽  
Concentration Data ◽  
Open Label Study ◽  
Content Type

ABSTRACTCeftolozane-tazobactam has potent activity againstPseudomonas aeruginosa, a pathogen associated with cystic fibrosis (CF) acute pulmonary exacerbations (APE). Due to the rapid elimination of many antibiotics, CF patients frequently have altered pharmacokinetics. In this multicenter, open-label study, we described the population pharmacokinetics and safety of ceftolozane-tazobactam at 3 g every 8 h (q8h) in 20 adult CF patients admitted with APE. Population pharmacokinetics were determined using the nonparametric adaptive grid program in Pmetrics for R. A 5,000-patient Monte Carlo simulation was performed to determine the probability of target attainment (PTA) for the ceftolozane component at 1.5 g and 3 g of ceftolozane-tazobactam q8h across a range of MICs using a primary threshold exposure of 60% free time above the MIC (fT>MIC). In these 20 adult CF patients, ceftolozane and tazobactam concentration data were best described by 2-compartment models, and ceftolozane clearance (CL) was significantly correlated with creatinine clearance (r= 0.71,P< 0.001). These data suggest that ceftolozane and tazobactam clearance estimates in CF patients are similar to those in adults without CF (ceftolozane CF CL, 4.76 ± 1.13 liter/h; tazobactam CF CL, 20.51 ± 4.41 liter/h). However, estimates of the volume of the central compartment (Vc) were lower than those for adults without CF (ceftolozane CFVc, 7.51 ± 2.05 liters; tazobactam CFVc, 7.85 ± 2.66 liters). Using a threshold of 60%fT>MIC, ceftolozane-tazobactam regimens of 1.5 g and 3 g q8h should achieve PTAs of ≥90% at MICs up to 4 and 8 μg/ml, respectively. Ceftolozane-tazobactam at 3 g q8h was well tolerated. These observations support additional studies of ceftolozane-tazobactam forPseudomonas aeruginosaAPE in CF patients. (This study has been registered at ClinicalTrials.gov under identifier NCT02421120.)

Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease

1998 ◽  
Vol 26 (3) ◽  
pp. 155-161 ◽  
Author(s):  
H. Karsten Harms ◽  
Elias Matouk ◽  
Guy Tournier ◽  
Horst von der Hardt ◽  
Peter H. Weller ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Lung Disease ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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