Impact of Triple Combination CFTR Therapy on Sinus Disease.

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT04056702
• Date of registration: 27/07/2019
• Prospective Registration: Yes
• Primary sponsor: Jennifer Taylor-Cousar
• Public title: Impact of Triple Combination CFTR Therapy on Sinus Disease.
• Scientific title: Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes
• Date of first enrolment: September 5, 2019
• Target sample size: 31
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04056702
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Jennifer TaylorCousar, M.D.
• Affiliation: National Jewish Health

• Name: Connor Balkissoon

• Name: Connor Balkissoon

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Elexacaftor-tezacaftor-ivacaftor exposure

Primary Outcome(s)

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

Secondary Outcome(s)

Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score. [Time Frame: Change in SNOT-22 score between the initial and 6 month visits.]

Change in Questionnaire for Olfactory Disorders (QOD) score [Time Frame: Change in QOD score between the initial and 6 month visits.]

Secondary ID(s)

HS-3236

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation