se of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF

Västra Götalandsregionen0 个研究点目标入组 100 人开始时间: 2020年4月22日最近更新: 2021年4月12日

适应症

试验速览

暂无简介。

•For inclusion in the study, subjects must fulfil the following criteria:
•1.Signed informed consent form to participate in the trial, from both patient and its legal guardians according to national regulations
•2.Diagnosis of Cystic Fibrosis
•3.Age 3.0 to 17.9 years
•4.MBW performed in the last 3 days with a relative increase in LCI =10% compared to former LCI
•5.Two MBW performed in stable condition before inclusion in the last year, both being <10.0 and relative difference less than 15% between each other 6MBW must be performed without sedation and fulfil pre-established quality criteria
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects must not enter the study if any of the following criteria are fulfilled:
•1. P. aeruginosa, A xyloxidans, B cepacia, NTM detected in sputum at inclusion
•2. Chronic infection with P. aeruginosa,,A xyloxidans, B cepacia or NTM
•3. Treated Acute Broncho pulmonary Aspergillosis at inclusion or in the last 12 months
•4. Started CFTR-modulator < 4 weeks before inclusion
•5. Change of inhalation therapy within last month (rhDNAse or hypertonic saline)
•6. Ongoing treatment with antibiotics or treated with antibiotics in the last 21 days (only group A)
•7. Started antibiotic treatment more than 5 days of before inclusion (=1st LCI) (only group B).
•8. Other contraindication according to responsible physician at respective CF center
•9. Being part in another CF trial
•10. Previous lung transplantation
•11. Pregnancy during the pre-screening period

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