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Recent news items on R&D and treatment of respiratory diseases, and news items on regulatory agencies such as the FDA, EMA, MHRA, Health Canada and others. 26 OctOber 2018 Inhalation RespiRatoRy medicine news NICE advises restricted use of antibiotics for COPD LONDON, UNITED KING- DOM—Pharma Times Online has reported that the UK's National Institute for Health and Care Excellence (NICE) is advising healthcare professionals to restrict use of antibiotics for treatment of chronic obstructive pulmonary dis- ease (COPD). e Institute recom- mends that the risk of antimicro- bial resistance be considered when deciding whether antibiotics are needed to treat a flare-up of COPD symptoms. It indicates that acute C O P D e x a c e r b a t i o n s c a n b e caused by a variety of factors, including viral infections and smoking, which would not respond to antibiotics. e Institute has also published a new clinical guideline for COPD diagnosis and manage- ment, which stresses that antibiot- ics should only be used for preven- tion of prevent flare-ups in patients most likely to benefit. Pulmonary Fibrosis Foundation patient registry surpasses 2,000 CHICAGO, ILLINOIS—When the Pulmonary Fibrosis Foundation (PFF) sought input on unmet needs from clinicians, scientific leaders and the patient community, it became clear that the absence of a large, nationwide patient registry and b i o re p o s i t o r y w a s re s t r i c t i n g researchers in taking critical steps toward a cure for pulmonary fibro- sis. With support from Genentech, Boehringer Ingelheim and other donors, the foundation has built a registry that recently achieved a milestone and now includes more than 2,000 patients. All registry data comes from patients seen at PFF Care Center sites, ensuring standard collection of high-quality informa- tion. The content is de-identified and includes symptoms, test results, use of PF medications, and informa- tion about progress in the years since enrollment. Participants may also contribute a blood sample. For ques- tions about submitting research pro- posals, contact ccn@pulmonaryfi e PFF is seeking addi- tional funding sources to expand the registry to 6,000 patients by 2020. Asthma, COPD readmissions independently predicted by chronic rhinitis CINCINATTI, OHIO—Pulmon- ology Advisor reported that a study in The Journal of Allergy and Clinical Immunology: In Practice showed that comorbid chronic rhinitis is signifi- cantly associated with 30-day hospi- tal readmissions related to asthma and chronic obstructive pulmonary disease (COPD). e retrospective study was conducted to determine which comorbid conditions could potentially trigger acute exacerba- tions of asthma and COPD and to help prevent early hospital readmis- sions. Data from the University of Cincinnati Hospitals between June 2012 and July 2017 was used. Results showed that 858 of 4,768 patients with a discharge diagnosis of asthma and 405 of 2,176 patients with a discharge diagnosis of COPD were readmitted to the hospital one or more times within 30 days after initial discharge; comprising 16.5% of all asthma-related and 15.5% of all COPD-related hospital encoun- ters. Comorbidities that inde- pendently determined a significant risk for 30-day hospital readmissions included allergic and nonallergic rhinitis, arrhythmia, diabetes, hypertension, obesity and tobacco use. e number of previous read- missions was also an independent determinant of risk. Noted researcher Kimishige Ishizaka dies at 92 LA JOLLA, CALIFORNIA—e New York Times has reported the death of immunologist Dr. Kim- ishige Ishizaka at age 92. He and his wife, research immunologist Teruko Ishizaka, conducted years of research on causes of severe allergic reactions in hypersensitive individuals. eir findings formed the basis for advances in monitoring, treating and preventing asthma, hay fever, and drug and food allergies. In the 1960s, his team first identified immunoglobulin E (IgE) and deter- mined it worked through a lock- and-key binding factor. In 1989, Dr. Ishizaka was named scientific direc- tor of the then-new La Jolla Insti- tute; he became its president in 1991. He and his wife wrote numer- ous articles together and shared sev- eral prizes for their research on IgE. RegulatoRy and compendial news MHRA outlines post-Brexit clinical trials regulation LONDON, UNITED KING- DOM—Pharmaceutical Times reported that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has outlined the way clinical trials regulation will function after the UK leaves the European Union (EU). An imple- mentation period will occur from March 30, 2019 to December 31, 2020, during which the UK will have market access under the exist- ing terms. In 2020, the EU is plan- ning to implement a new Clinical Trials Regulation (CTR), which would apply to the UK during the implementation period. e CTR is intended to optimize application processes and assessment proce- dures, simplify reporting and offer one portal for all EU clinical trials. e UK was involved in developing the new rules. If the CTR does not come into effect during the imple- mentation period, the UK plans to retain alignment with parts of the CTR that are under its control. After the implementation period, the UK will not be able to use a shared cen- tral IT portal or participate in the single assessment model, unless they come to an agreement with the EU. An MHRA statement was quoted as saying, "It is in the interest of patients and the life sciences indus- try internationally for the UK and EU to find a way to continue coop- eration in the field of clinical trials, and for continued sharing of data, even if our precise relationship with the EU will by necessity change… No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment."

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