Randomized trial of efficacy and safety of dornase alfa delivered by eRapid nebulizer in cystic fibrosis patients

التفاصيل البيبلوغرافية
العنوان: Randomized trial of efficacy and safety of dornase alfa delivered by eRapid nebulizer in cystic fibrosis patients
المؤلفون: Gregory S. Sawicki, Michael W. Konstan, Will Chou, Karina Raimundo, Ben Trzaskoma
المصدر: Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 14(6)
سنة النشر: 2014
مصطلحات موضوعية: Pulmonary and Respiratory Medicine, Male, Vital capacity, medicine.medical_specialty, Adolescent, Cystic Fibrosis, Cystic fibrosis, law.invention, Randomized controlled trial, law, medicine, Clinical endpoint, Deoxyribonuclease I, Humans, Child, Intention-to-treat analysis, business.industry, Nebulizers and Vaporizers, Dornase alfa, medicine.disease, Crossover study, Recombinant Proteins, Surgery, Nebulizer, Treatment Outcome, Anesthesia, Pediatrics, Perinatology and Child Health, Female, business, medicine.drug
الوصف: Background Dornase alfa administered via jet nebulizer is indicated as a chronic respiratory medication for cystic fibrosis (CF) patients. Efficacy and safety of dornase alfa via an electronic nebulizer with vibrating membrane technology have not been formally assessed in randomized clinical trials. Methods 87 CF patients (≥6years) were randomized in a crossover study to receive dornase alfa 2.5mg/d in 2-week periods with the Pari eRapid and Pari LC Plus jet nebulizers. The primary end point was comparison of forced expiratory volume in the first second. Safety, quality of life, and treatment satisfaction/preference were also compared between devices. Results Lung function was equivalent between nebulizers. Most domain scores from the Cystic Fibrosis Questionnaire-Revised and Treatment Satisfaction Questionnaire for Medication instruments were similar but patients strongly preferred the eRapid. Mean patient-reported administration times were shorter with the eRapid vs the LC Plus (2.7 vs 10.2min). Adverse events were similar between devices. Conclusions Administration of dornase alfa via the eRapid nebulizer resulted in comparable efficacy and safety, shorter nebulization times, and higher patient preference.
تدمد: 1873-5010
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b02143647e571d0b4c02c734a0c3476dTest
https://pubmed.ncbi.nlm.nih.gov/25921451Test
حقوق: OPEN
رقم الانضمام: edsair.doi.dedup.....b02143647e571d0b4c02c734a0c3476d
قاعدة البيانات: OpenAIRE