ACTRN12624000696594
Recruiting
未知
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).
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- Sydney Local Health District
- Enrollment
- 313
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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