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Veronica Chorro-Mari, Nanna Christiansen
AIM: Due to national changes to the commissioning process of high cost nebulisers (HCN) for Cystic Fibrosis (CF) patients, CF centres have to repatriate the prescribing of the HCN to the tertiary care centres.1 The following nebulisers will no longer be prescribed by primary care: Cayston® (Aztreonam); Colomycin®, Pomixin®, Clobreathe® (Colistimethate); Pulmozyme® (Dornase alfa); Tobi®, Tobi Podhaler ®, Bramitob® (Tobramycin).This abstract explains how the Royal London Hospital (RLH) Paediatric Pharmacy recruited over 100 paediatric (CF) patients smoothly within a period of 4 months and set up a homecare system to avoid patients and families having to travel large distances to obtain their medication...
September 2016: Archives of Disease in Childhood
Mieke Boon, Mark Jorissen, Martine Jaspers, Patrick Augustijns, François L Vermeulen, Marijke Proesmans, Kris De Boeck
INTRODUCTION: Nebulized drugs are used in the treatment of cystic fibrosis (CF) lung disease, asthma, and COPD, and increasingly also in other chronic lung diseases. Their use in CF is reasonably evidence based, but this is not so for use in other orphan diseases. Potential side effects often have not been studied. Therefore, we evaluated the influence of nebulized drugs on ciliary activity in an in vitro model. METHODS: We constructed an in vitro nebulization model to examine the effect of drugs on ciliary activity...
August 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Iain Simpson, James Blakemore
This Industry Update covers the period from 1 January through 31 January, 2015, and is based on information sourced from company press releases, scientific literature, patents and various news websites. This month saw drugs from Shire and Janssen win fast track approval status from the US FDA which reduces the target time for the Agency to take action from 10 to 6 months. Sanofi and Regeneron also heard that they have won fast track approval for alirocumab a PCSK9 inhibitor for cholesterol lowering following their purchase of a 'Priority Review Voucher' from BioMarin...
April 2015: Therapeutic Delivery
Robert Bucki, Katrina Cruz, Katarzyna Pogoda, Ashley Eggert, LiKang Chin, Marianne Ferrin, Giovanna Imbesi, Denis Hadjiliadis, Paul A Janmey
BACKGROUND: DNase (Pulmozyme) effectiveness in cystic fibrosis treatment is in some cases limited by its inability to access DNA trapped within bundles in highly viscous fluids that also contain actin. Dissociating DNA-containing bundles using actin depolymerizing agents and polyanions has potential to increase DNase efficacy. METHODS: Fluorescence measurements of YOYO-1 and a rheological creep-recovery test quantified DNA content and viscoelasticity in 150 sputum samples from adult CF patients and their susceptibility to fluidization by DNase1, alone and in combination with gelsolin and poly-aspartate (p-Asp)...
September 2015: Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society
Don B Sanders, Zhanhai Li, Alan S Brody
RATIONALE: Abnormalities on chest computed tomography (CT) in children with cystic fibrosis (CF) have been shown to correlate with short-term measures of lung disease. Chest CT scores offer promise as a potential surrogate end point in CF; however, there is limited information available on the ability of chest CT scores to predict future morbidity. OBJECTIVES: Determine whether chest CT scores are associated with the rate of pulmonary exacerbations over the next 10 years...
January 2015: Annals of the American Thoracic Society
Rossella Grande, Laura Nistico, Karthik Sambanthamoorthy, Mark Longwell, Antonio Iannitelli, Luigina Cellini, Antonio Di Stefano, Luanne Hall Stoodley, Paul Stoodley
Extracellular DNA (eDNA) is an important component of the extracellular polymeric substance matrix and is important in the establishment and persistence of Staphylococcus aureus UAMS-1 biofilms. The aim of the study was to determine the temporal expression of genes involved in early biofilm formation and eDNA production. We used qPCR to investigate expression of agrB, which is associated with secreted virulence factors and biofilm dispersal, cidA, which is associated with biofilm adherence and genomic DNA release, and alsS, which is associated with cell lysis, eDNA release and acid tolerance...
April 2014: Pathogens and Disease
Samya Z Nasr, Will Chou, Kathleen F Villa, Eunice Chang, Michael S Broder
OBJECTIVE: To investigate adherence to dornase alfa therapy among commercially-insured patients with cystic fibrosis (CF) and to examine the impact of adherence on health and economic outcomes. METHODS: This retrospective cohort analysis included CF patients with ≥1 dornase alfa (Pulmozyme) pharmacy claim between 1 October 2006 and 30 September 2008 and with continuous enrollment in the health insurance plan at least 1 year before and 1 year after their index dornase alfa claim...
2013: Journal of Medical Economics
Jessica Nutik Zitter, Pierre Maldjian, Michael Brimacombe, Kevin P Fennelly
BACKGROUND: Lobar or segmental collapse of the lung in mechanically ventilated patients is a common occurrence in the intensive care unit. Management is labor and time intensive and not highly effective. METHODS: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized Dornase alfa improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Drug or placebo was administered twice daily until extubation, death, or transfer...
April 2013: Journal of Critical Care
Goetz Parsiegla, Christophe Noguere, Lydia Santell, Robert A Lazarus, Yves Bourne
Recombinant human DNase I (Pulmozyme, dornase alfa) is used for the treatment of cystic fibrosis where it improves lung function and reduces the number of exacerbations. The physiological mechanism of action is thought to involve the reduction of the viscoelasticity of cystic fibrosis sputum by hydrolyzing high concentrations of DNA into low-molecular mass fragments. Here we describe the 1.95 Å resolution crystal structure of recombinant human DNase I (rhDNase I) in complex with magnesium and phosphate ions, both bound in the active site...
December 21, 2012: Biochemistry
Jeffrey S Wagener, Oren Kupfer
PURPOSE OF REVIEW: Dornase alfa (Pulmozyme) is one of the most commonly used medications to treat the lung disease of cystic fibrosis (CF). As other respiratory medications have entered the clinical market, understanding the proper use and indication for dornase alfa is increasingly important. In addition, dornase alfa is being used to treat other medical conditions. This review covers recent publications and expanding indications. RECENT FINDINGS: Understanding dornase alfa's mechanism of action and impact on the pathophysiology of CF leads to an improved understanding of optimal therapy, ways to improve adherence and use with other medications...
November 2012: Current Opinion in Pulmonary Medicine
Aaron Shaw, Daniela Bischof, Aparna Jasti, Aaron Ernstberger, Troy Hawkins, Kenneth Cornetta
In the production of lentiviral vector for clinical studies the purity of the final product is of vital importance. To remove plasmid and producer cell line DNA, investigators have incubated the vector product with Benzonase, a bacterially derived DNase. As an alternative we investigated the use of Pulmozyme, a U.S. Food and Drug Administration-approved human DNase for the treatment of cystic fibrosis, by comparing the efficiency of DNA removal from lentiviral vector preparations. A green fluorescent protein-expressing lentiviral vector was prepared by transient calcium phosphate transfection of HEK 293T cells and DNA removal was compared when treating vector after harvest or immediately after transfection...
February 2012: Human Gene Therapy Methods
Tatiana Rozov, Viviane Ziebell de Oliveira, Maria Angélica Santana, Fabíola Villac Adde, Rita Heloisa Mendes, Ilma Aparecida Paschoal, Francisco J Caldeira Reis, Laurinda Yoko Shinzato Higa, Antonio Carlos de Castro Toledo, Márcia Pahl et al.
SUMMARY BACKGROUND: Health-related quality of life (HRQOL) measurements provide valuable information about the psychological and social impact of treatment on patients with cystic fibrosis (CF). This study evaluated the HRQOL of Brazilian patients with CF and assessed the changes in HRQOL domains over 1 year after dornase alfa (Pulmozyme) introduction. PATIENTS AND METHODS: One hundred fifty-six stable patients with CF and 89 caregivers answered the Portuguese-validated version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline (T(0)), and at 3 (T(1)), 6 (T(2)), 9 (T(3)), and 12 (T(4)) months of follow-up...
September 2010: Pediatric Pulmonology
Anne Marie McLaughlin, Emmet McGrath, Rupert Barry, Jim J Egan, Charles G Gallagher
INTRODUCTION: Recombinant human deoxyribonuclease (rhDNase) reduces sputum viscosity and improves pulmonary function in cystic fibrosis (CF). OBJECTIVE: The objective of this study was to describe our experience in which rhDNase (Pulmozyme; Roche, Basel, Switzerland) was administered by bronchoscopic instillation into atelectatic lobes in five adults with CF. CONCLUSION: We found this method successful in treating lobar atelectasis, which was resistant to conventional therapy with antibiotics and physiotherapy...
April 2008: Clinical Respiratory Journal
M J Alcorn, L J Richmond, E Farrell, J Barr, C Pearson, R Schupp, I M Franklin
BACKGROUND: It has been reported previously that PBPC can be recovered from cryopreservation and can be efficiently CD34-selected, to provide a product of high purity (> 80% CD34) with good yield (> 50% recovery). METHODS: In this study, we have investigated the effects of thawing and CD34-selecting cryopreserved PBPC in the presence of recombinant human deoxyribonuclease (rhDNase; Pulmozyme) and magnesium chloride (MgCl2 injection). RESULTS: The addition of Pulmozyme and MgCl2 significantly improves the yield of CD34+ cells, compared with the standard procedure (65...
1999: Cytotherapy
Irene Krämer, Astrid Schwabe, Ralf Lichtinghagen, Wolfgang Kamin
Patients suffering from cystic fibrosis (CF) often need to inhale multiple doses of different nebulizable drugs per day. Patients attempt to shorten the time consuming administration procedure by mixing drug solutions/suspensions for simultaneous inhalation. The objective of this experimental study was to determine whether mixtures of the nebulizer solution dornase alfa (Pulmozyme) with tobramycin nebulizer solutions (TOBI and GERNEBCIN 80 mg) are physico-chemically compatible. Drug combinations were prepared by mixing the content of one respule Pulmozyme with either one respule TOBI or one ampoule GERNEBCIN 80 mg...
February 2009: Pediatric Pulmonology
I Krämer, A Schwabe, R Lichtinghagen, W Kamin
Patients suffering from cystic fibrosis (CF) often need to inhale multiple doses of different nebulizable drugs per day. Patients attempt to shorten the time consuming administration procedure by mixing drug solutions/suspensions for simultaneous inhalation. The objective of this experimental study was to determine whether mixtures of Pulmozyme inhalation solution with Atrovent or Sultano are physicochemically compatible. Drug combinations were prepared in accordance with the product information and clinical practice by mixing the content of one respule Pulmozyme with 2 mL Atrovent LS and 0...
October 2007: Die Pharmazie
Wenjing Wang, Lisa Upshaw, Guangming Zhang, D Michael Strong, Jo-Anna Reems
Despite improvements and recent attempts to standardize techniques to isolate islets from human donor pancreata, there still exists the problem of consistently recovering sufficient quantities of high quality islets. Moreover, achieving consistent recoveries of high numbers of good quality islets becomes even more challenging from marginal grade human donor pancreata with prolonged cold ischemic times. In this study, we investigate whether addition of Pefabloc SC, a serine protease inhibitor, in combination with Pulmozyme, a recombinant human DNase I, to Liberase HI improves islet isolation outcome from marginal grade human donor pancreata (cold ischemic time > 12 h)...
2007: Cell and Tissue Banking
Birgitte Frederiksen, Tacjana Pressler, Annelise Hansen, Christian Koch, Niels Høiby
BACKGROUND: Aerosolized recombinant human deoxyribonuclease (rhDNase I (Pulmozyme)) has previously been shown to increase pulmonary function and reduce exacerbations of respiratory symptoms in cystic fibrosis (CF) patients with moderate to severe reduction in pulmonary function. AIM: To analyse whether aerosolized Pulmozyme could reduce the number of bacterial infections in the lower respiratory airways of CF patients without chronic pulmonary infection. METHODS: Patients were randomized either to aerosolized Pulmozyme 2(1/2) mg once daily or to no rhDNase treatment...
September 2006: Acta Paediatrica
Ralf Lichtinghagen
An enzymatic activity assay was developed for the determination of dornase alpha human recombinant desoxyribonuclease (DNase I) stability. The method was adapted from a colorimetric endpoint enzyme activity assay for DNase I based on the degradation of a DNA/methyl green complex. With the described modifications the kinetic measurement of enzyme activity is feasible on an automated analyzer system within a rather short time. The development of this assay was based on the need for reliable detection of a possible loss of enzyme activity after transferring the commercial therapeutic agent into sealed glass vials required for a placebo-controlled study...
July 2006: European Journal of Pharmaceutics and Biopharmaceutics
W Kamin, B Klär-Hlawatsch, H Truebel
Mucoid impaction and plastic bronchitis are relatively rare disorders affecting patients of any age. Here we report the case of mucoid impaction developing in a four-year-old child as a complication of pneumonic infection treated four weeks prior. p.a. chest X-ray and fiberoptic bronchoscopy showed atelectasis and the location of a mucus cast in the left upper lobe. After extraction of the cast via the suction channel of the bronchoscope had failed, we administered 2.5 mg of undiluted recombinant human deoxyribonuclease (rhDNase) instilled directly over the affected area of occlusion for 15 minutes...
March 2006: Klinische Pädiatrie
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