The effect of reducing the frequency of outpatient review in people with cystic fibrosis on high-efficacy modulator therapy – a non-inferiority, randomised controlled trial (REFORM).

Sydney Local Health District0 个研究点目标入组 313 人开始时间: 2024年5月31日最近更新: 2024年9月9日

适应症

试验速览

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•1.Adult (18 years and older) participants with cystic fibrosis
•2.Taking Highly Effective Modulator Therapy (HEMT) for 3 months or longer
•3.Willing to provide informed consent and willing to participate and comply with study requirements.
•4.Enrolled to the Australian Cystic Fibrosis Data Registry

•1.Exacerbation within the last 28 days
•2.History of hospitalization for CF respiratory exacerbation in the past 12 months
•3.ppFEV1 < 40% (on HEMT)
•4.Antibiotic treatment for non-tuberculous mycobacterial disease within the past 28 days
•5.Changes to chronic therapies (for example nebulized therapies, azithromycin) within the past 28 days
•6.Use of an investigational product within the past 28 days
•7.New growth of Pseudomonas, Mycobacterium abscessus and Burkholderia cepacia complex within the past 90 days
•8.Transition from paediatric to adult care within the last 12 months
•9.Women who are pregnant
•10.Prior lung transplant
•11.Unstable extrapulmonary cystic-fibrosis-related disease
•12.Other comorbidities which in the opinion of the investigator would make participation unsafe

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