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Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome
Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Adults unable to consent * Individuals who are not yet adults * Prisoners
About the study
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.
What is being tested
- Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge (other)
- Olfactory Function Testing (other)
- Survey Completion (other)
Sponsor: Dartmouth-Hitchcock Medical Center · Participants: 30 · Started: Nov 8, 2023
Contact the study team
- Ryan E Little, MD · Phone: (603) 650 8123
Official record on ClinicalTrials.gov — NCT05982795
Locations in the U.S.
| New Hampshire | Dartmouth-Hitchcock Medical Center, Lebanon |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.