Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
The goal of this observational study is to learn about the effects of a specific cystic fibrosis therapy (Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy) on chronic sinonasal disease. The main questions it aims to answer are: 1. How does this therapy impact bacterial communities in the paranasal sinuses? 2. How does this therapy impact inflammation in the paranasal sinuses and olfactory cleft? 3. How does this therapy impact sense of smell and sinonasal disease burden in individuals with cystic fibrosis? 4. How does this therapy impact disease-specific and general quality of life of individuals with cystic fibrosis? Participants will be asked to provide samples from their nose, complete testing of their sense of smell, and complete surveys about their quality of life and sense of smell in this study. Researchers will compare study results between patients who are currently undergoing Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy and patients who are not currently undergoing therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive)
• English-speaking
• Diagnosed with CF as established by genetic testing combined with clinical assessment and/or sweat chloride
• Patients being seen at the New Hampshire Cystic Fibrosis Center
• Adults able to sign informed consent
Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Ryan E Little, MD
Ryan.E.Little@hitchcock.org
(603) 650 8123
Backup
Michaela M Geffert, BS
michaela.m.geffert@hitchcock.org
Time Frame
Start Date:2023-11-08
Estimated Completion Date:2026-12-01
Participants
Target number of participants:30
Treatments
CFTR-MT Group
The cohort of adult cystic fibrosis patients that are currently on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT) will be asked to complete the following research activities at baseline and every six months following for a two-year period.~1. Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge~2. The Sniffin' Sticks extended test kit and/or the University of Pennsylvania Smell Identification Test (UPSIT)~3. 4 validated quality of life questionnaires:~ 1. Cystic Fibrosis Questionnaire Revised (CFQ-R)~ 2. Sino-Nasal Outcome Test-22 (SNOT-22)~ 3. Sinus Control Test (SCT)~ 4. Questionnaire of Olfactory Disorders
Non-CFTR-MT Group
The cohort of adult cystic fibrosis patients that are not currently on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT) will be asked to complete the following research activities at baseline and every six months following for a two-year period.~1. Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge~2. The Sniffin' Sticks extended test kit and/or the University of Pennsylvania Smell Identification Test (UPSIT)~3. 4 validated quality of life questionnaires:~ 1. Cystic Fibrosis Questionnaire Revised (CFQ-R)~ 2. Sino-Nasal Outcome Test-22 (SNOT-22)~ 3. Sinus Control Test (SCT)~ 4. Questionnaire of Olfactory Disorders