Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT05982795
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge — OTHER
    A CultureSwab MaxV(+) (BD, Franklin Lakes, NJ) will be placed under endoscopic visualization to the middle meatus through a sterile sheath (red rubber urinary catheter) and gently rotated 5 full turns or until the tip is saturated with mucus (no more than 20 seconds). Under direct visualization, a sterile Leukosorb sponge (Leukosorb; Pall Scientific, Port Washington, NY) will be placed in the middle meatus. A piece of Leukosorb filter paper will additionally be placed in the olfactory cleft. The sponge and paper will be left for 5 minutes and will then be removed under direct visualization and collected for analysis.
  • Olfactory Function Testing — OTHER
    Olfactory function will be tested using the Sniffin' Sticks extended test kit (MediSense, NL) using the established threshold, discrimination, and identification (TDI) scoring system. Odors will be delivered using felt-tip pens (Sniffin' Sticks, MediSense, NL). The pen cap will be removed from the pen for approximately 3 seconds, and the pen's tip will be brought in front of the subject's nose and carefully moved from left to right nostril. Threshold testing will be obtained by asking the subject to identify the pen containing the odor from two pens containing only solvent. This will be conducted starting with the lowest concentration of odor and moving stepwise until patient is no longer able to identify the odor from the solvent. Subjects may also be asked to complete the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT can be self-administered and uses microencapsulated odorants which are released by scratching standardized odor-impregnated test booklets.
  • Survey Completion — OTHER
    Participants will be asked to complete the validated Cystic Fibrosis Questionnaire-Revised (CFQ-R) survey. This survey evaluates Cystic Fibrosis-specific and general quality of life metrics. Participants will also be asked to complete the validated Sino-nasal Outcome Test-22 (SNOT-22) which is the most commonly used survey for evaluating outcomes in patients with chronic rhinosinusitis. Participants will also be asked to complete the validated Sinus Control Test (SCT) - a 4-question questionnaire that assesses disease control in chronic rhinosinusitis. Participants will be asked to complete the questionnaire of olfactory disorders (QOD). This is a 25-question validated survey used to assess the impact of olfactory dysfunction on patients with sinonasal disease.

Study Details

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.

Key Dates

Start date
Nov 8, 2023
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Difference in nasal bacterial community composition between CFTR-MT cohort and Non-CFTR-MT cohort [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-

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