← Back to Search

CFTR Modulator

Trikafta for Bronchiectasis

Phase 4
Recruiting
Led By Eric Sorscher, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of 1 CF-causing mutation and/or sweat chloride measurement ≥ 30 mEq/L and < 60 mEq/L
Able to perform spirometry meeting American Thoracic Society (ATS) criteria for acceptability and repeatability, and FEV1 40-90% predicted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 14, day 28, day 56
Awards & highlights

Study Summary

This trial will study the effects of Trikafta on non-cystic fibrosis bronchiectasis sufferers, measuring clinical endpoints, quality of life and weight, plus collecting biopsy material to test cellular response.

Who is the study for?
This trial is for individuals with non-cystic fibrosis bronchiectasis who can perform spirometry tests and have a certain level of lung function. Participants must not be pregnant, breastfeeding, or have used CFTR modulators in the last 6 months. They should agree to use birth control during the study and remain clinically stable without exacerbations for 4 weeks prior.Check my eligibility
What is being tested?
The trial is testing Trikafta on patients with non-cystic fibrosis bronchiectasis over four weeks, monitoring clinical outcomes, quality of life, and weight changes. It also involves collecting skin samples to examine cellular responses to the medication.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to Trikafta or interactions with other medications. Side effects could range from mild symptoms like headaches or digestive issues to more serious conditions affecting liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a CF mutation or my sweat chloride test shows 30-59 mEq/L.
Select...
My lung function test meets specific standards and my FEV1 score is between 40-90% of the expected value.
Select...
I can take Trikafta without any issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Forced Expiratory Volume in One Second (FEV1).
Short Circuit Current Measurements in Monolayers
Western Blot Analysis
Secondary outcome measures
Change in Body Mass Index (BMI)
Change in Quality of Life-Bronchiectasis (QOL-B) Score
Change in Sweat Chloride Test
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TrikaftaExperimental Treatment1 Intervention
Participants with NCFBE and one known CFTR mutation and/or mildly elevated sweat chloride measurements (i.e., 30-60 mEq/L) receiving Trikafta for four weeks.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,502 Total Patients Enrolled
The Marcus Foundation, Inc.UNKNOWN
Eric Sorscher, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Trikafta (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05743946 — Phase 4
Bronchiectasis Research Study Groups: Trikafta
Bronchiectasis Clinical Trial 2023: Trikafta Highlights & Side Effects. Trial Name: NCT05743946 — Phase 4
Trikafta (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743946 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Trikafta a viable solution for treating patients with minimal risk?

"The safety of Trikafta was rated a 3, which reflects it being in the fourth and final trial phase - meaning that this treatment has been approved by the appropriate regulatory bodies."

Answered by AI

How many participants are being monitored in this research study?

"Affirmative. The trial is currently accepting patients, with its posting date being February 1st 2023 and last update occurring on the 15th of that same month. In total, 30 people are sought from a single site."

Answered by AI

Are there opportunities to join the clinical trial currently available?

"Affirmative. According to information provided on the clinicaltrials.gov website, this experiment is currently recruiting participants. This trial was initially posted on February 1st 2023 and most recently updated on February 15th 2023; its goal is to enrol 30 individuals at a single medical centre."

Answered by AI

What salient goals are the research team attempting to achieve with this investigation?

"This trial has a primary objective of evaluating the efficacy of this intervention via Western Blot Analysis. Secondary objectives include assessing changes in Quality of Life-Bronchiectasis (QOL-B) Score, Weight and Body Mass Index (BMI). The QOL-B is a 37 item survey with responses ranging from 1 to 4 that measures Respiratory Symptoms, Physical Functioning, Role Performance, Emotional Wellbeing Social Functioning Vitality Health Perceptions and Treatment Burden. Changes in weight will be measured in kilograms (kg), while BMI will be calculated as bodyweight divided by the square of bodyheight expressed in kg/"

Answered by AI

Who else is applying?

What site did they apply to?
The Emory Clinic
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have bronchiectasis, asthma and latex allergy. A sibling with cf. recurrent lung infections.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis
Eric Sorscher 2023. "Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05743946.
All > Bronchiectasis > Cystic Fibrosis
~2 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top