Recruiting

Triple Combination CFTR Therapy

Sponsor:

Jennifer Taylor-Cousar

Code:

NCT04056702

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Elexacaftor-tezacaftor-ivacaftor exposure

Study Details

Brief summary:

The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.

Conditions

Cystic Fibrosis

Study ID

NCT04056702

Start date

Sep 5, 2019

Status verified date

Mar, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects from 18 to 89 years old.
2. Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record).
3. Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride > 90 mmol/L.

Exclusion Criteria:

1. Subjects under the age of 18 or over the age of 89.
2. Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons.
3. Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period.
4. Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.

Study Design

Enrollment

31 participants

Anticipated

Interventions and Outcome Measures

Arms

Prescribed triple combination

A group of 60 people with CF who are clinically prescribed elexacaftor-tezacaftor-ivacaftor and have chronic sinusitis

Not eligible for modulators

A group of 10 patients with two class I/II mutations who are ineligible for elexacaftor-tezacaftor-ivacaftor based on their genotype and have chronic sinusitis.

Interventions

Elexacaftor-tezacaftor-ivacaftor exposure

Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study.

Primary outcome measure

  • Change in Sinus CT opacification. [ Time Frame: Change in Sinus CT opacification between the initial and 6 month visits. ]

Central Contacts and Locations

Central contacts

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

More Information

Sponsor

Jennifer Taylor-Cousar

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Keywords

  • Chronic Sinusitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jennifer Taylor-Cousar on 2021-03-11.