Status:
COMPLETED
Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy
Lead Sponsor:
Nicole Hamblett
Collaborating Sponsors:
Cystic Fibrosis Foundation
Dartmouth-Hitchcock Medical Center
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies...
Detailed Description
SIMPLIFY-IP-19 is a master protocol is designed to evaluate the independent effects of discontinuing hypertonic saline or dornase alfa in people with cystic fibrosis (CF) age 12 and older currently ta...
Eligibility Criteria
Inclusion
- Diagnosis of CF.
- Age ≥ 12 years at the Screening Visit.
- Forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit if \< 18 years old, and ≥ 60 % predicted at Screening Visit if ≥ 18 years old.
- Clinically stable with no significant changes in health status within the 7 days prior to and including the Screening Visit.
- Current treatment with elexacaftor/tezacaftor/ivacaftor (ETI) for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the duration of the study.
- Currently taking hypertonic saline (at least 3%) and/or dornase alfa for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the 2-week screening period.
Exclusion
- Active smoking or vaping.
- Use of an investigational drug within 28 days prior to and including the Screening Visit.
- Changes to chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, aztreonam lysine) within 28 days prior to and including the Screening Visit. This includes new airway clearance routines.
- Acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 7 days prior to and including the Screening Visit.
- Chronic use of systemic corticosteroids at a dose equivalent to ≥ 10mg per day of prednisone within 28 days prior to and including the Screening Visit.
- Antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
987 Patients enrolled
Trial Details
Trial ID
NCT04378153
Start Date
August 25 2020
End Date
July 11 2022
Last Update
December 4 2024
Active Locations (80)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
3
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States, 85724
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202