Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis
NCT05743946 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-02-09
Summary
Study participants with non-cystic fibrosis bronchiectasis will be given Trikafta for four weeks. The researchers will monitor clinical endpoints, quality of life, and weight. Additionally, cutaneous punch biopsy material material or blood samples from participants who agree to do this optional test will be collected to test cellular response to Trikafta.
Conditions
- Non-cystic Fibrosis Bronchiectasis
Interventions
- DRUG
-
Participants will be given elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (two pills once daily in the morning) and ivacaftor 150 mg (once daily in the evening), as the FDA-registered agent, Trikafta. Dose and schedule will be for 28 days, and otherwise identical to what has already been FDA-approved for effective treatment of cystic fibrosis.
Sponsors & Collaborators
-
The Marcus Foundation
collaborator OTHER -
Emory University
lead OTHER
Principal Investigators
-
Eric Sorscher, MD · Emory University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-18
- Primary Completion
- 2025-12-23
- Completion
- 2025-12-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
NCT04308681 ·Status: COMPLETED ·Phase: PHASE2
-
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
NCT03538301 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT03591926 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT02477709 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
NCT07344558 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis
NCT02035488 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of HSK31858 in Participants with Non-Cystic Fibrosis Bronchiectasis
NCT05601778 ·Status: COMPLETED ·Phase: PHASE2
-
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
NCT03865927 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT06317285 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)
NCT03482713 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
NCT05389215 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
NCT03696108 ·Status: COMPLETED ·Phase: PHASE3
-
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
NCT05628740 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)
NCT03449134 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
NCT04525885 ·Status: COMPLETED ·Phase: PHASE3
-
Atezolizumab for Idiopathic Pulmonary Fibrosis
NCT05515627 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation
NCT04656275 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT03832946 ·Status: COMPLETED ·Phase: PHASE2
-
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
NCT06280391 ·Status: COMPLETED ·Phase: PHASE2
-
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
NCT05010577 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
NCT03287414 ·Status: TERMINATED ·Phase: PHASE2
-
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
NCT06331624 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT00047658 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis
NCT02950805 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
NCT05495243 ·Status: COMPLETED ·Phase: PHASE2