Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
Not provided
Not provided
Not provided
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.
To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus CT scan and complete questionnaires related to signs and symptoms of sinus disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elexacaftor-tezacaftor-ivacaftor exposure | Drug | Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sinus CT opacification. | Calculated from an automated quantification of the size of sinuses. | Change in Sinus CT opacification between the initial and 6 month visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score. | Validated, disease-specific measure of sinus symptoms. Contains 22 questions that are all scored from 0 to 5, when summed a total score ranges form 0 to 110. Higher scores represent worse sinus symptoms. | Change in SNOT-22 score between the initial and 6 month visits. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
People with cystic fibrosis and chronic sinusitis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connor Balkissoon | Contact | 877-225-5654 | 2768 | balkissoonc@njhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer TaylorCousar, M.D. | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Recruiting | Denver | Colorado | 80206 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Questionnaire for Olfactory Disorders (QOD) score |
Validated, disease-specific measure of olfaction, i.e. the ability to smell. Contains 19 questions that are scored form 0 to 3, when summed a total score can range form 0 to 57. Higher scores indicate greater impact on a subjects sense of smell. |
| Change in QOD score between the initial and 6 month visits. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |