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NCT05982795Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
1 Aug 2023
Start date
8 Nov 2023
Primary completion date
1 Dec 2026
Lead sponsor
Dartmouth-Hitchcock Medical Center
NCT number
NCT05982795

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 8 Nov 2023 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Adults unable to consent
  • Individuals who are not yet adults
  • Prisoners

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Dartmouth Hitchcock Medical Center
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.