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

Not Applicable

Recruiting

Conditions: Cystic Fibrosis
Respiratory - Other respiratory disorders / diseases

Registration Number: ACTRN12624000696594

Lead Sponsor: Sydney Local Health District

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 313

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
11.Unstable extrapulmonary cystic-fibrosis-related disease
12.Other comorbidities which in the opinion of the investigator would make participation unsafe

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lung function (percent predicted forced expiratory volume in 1 second, ppFEV1) between groups at 24 months post randomization[Difference in the change in lung function (percent predicted forced expiratory volume in 1 second, ppFEV1) at recruitment compared to 24 months post randomization measured via spirometry. At recruitment compared to 24 months post randomization]

Secondary Outcome Measures