Cystic FibrosisNCT05982795
Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome
An observational study of Cystic Fibrosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge, Olfactory Function Testing and Survey Completion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is adult, English-speaking cystic fibrosis patients being seen at the New Hampshire Cystic Fibrosis Center.
Who may be able to join
- 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
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michaela M Geffert, BS contact
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis
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:
- How does this therapy impact bacterial communities in the paranasal sinuses?
- How does this therapy impact inflammation in the paranasal sinuses and olfactory cleft?
- How does this therapy impact sense of smell and sinonasal disease burden in individuals with cystic fibrosis?
- How does this therapy impact disease-specific and general quality of life of individuals with cystic fibrosis?
Read more
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.
Read the detailed description
The goal of this study is to characterize the effects of Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy on the sinonasal microbial communities and inflammatory profiles in adults with cystic fibrosis. Participants will be asked to complete the below research activities on a 6-month basis over the course of two years to total 5 research visits (0 months, 6 months, 12 months, 18 months, 24 months).
A mucus sample from the middle meatus will be obtained and stored at 4ºC until culture analysis. Semi-quantitative bacterial cultures will be performed. Bacterial community composition will be quantified using 16S rRNA variable region (V4) amplicon sequencing and qPCR. Data preprocessing and taxonomic assignment will be performed using QIIME 2 (v 2023.2) and the SILVA 138.1 rRNA database. Abundance data will be further processed in R (v 4.3.0) using packages decontam, phyloseq, and vegan.
Samples from the middle meatus and olfactory cleft will be analyzed to investigate the inflammatory profiles of patients with cystic fibrosis. Both samples will be centrifuged at 4°C, 10,000 rpm for 10 minutes to extract the entire sample from the material. Samples will be transferred by pipette to cryovials, flash-frozen in liquid nitrogen, and stored in a -80°C environment until time of laboratory assay. The study will assess changes in immune status through cytokine arrays. To assess innate immune responses, a Bioplex Pro Human Inflammation Assay for 37 human cytokines (BD Biosciences) will be employed.
The study will also investigate if alterations in nasal microbiome and inflammatory profile correlate with changes in cystic fibrosis-specific quality of life (QOL) and olfaction outcomes. Participants will be asked to complete olfactory function testing using the Sniffin' Sticks extended test kit (MediSense, NL) and/or the University of Pennsylvania Smell Identification Test (UPSIT). Additionally, participants will be asked to complete the four following surveys to assess their quality of life as it relates to sinus symptom severity, disease control, and sense of smell: Cystic Fibrosis Questionnaire-Revised, Sino-nasal Outcome Test-22, Sinus Control Test, and Questionnaire of Olfactory Disorders.
- Conditions
- Cystic Fibrosis
- Being tested
- Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge, Olfactory Function Testing, Survey Completion
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal endoscopy with microbiome swab and mucus collection through filter paper and spongeOther
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 TestingOther
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 CompletionOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge; Other: Olfactory Function Testing; Other: Survey Completion | |
| 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 Receives: Other: Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge; Other: Olfactory Function Testing; Other: Survey Completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in nasal bacterial community composition between CFTR-MT cohort and Non-CFTR-MT cohort
Difference in microbial communities in mucus swabs between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not on CFTR-MT.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in inflammatory profiles between CFTR-MT cohort and Non-CFTR-MT cohort
Difference in microbiome swab cytokine assay results between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not of CFTR-MT.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes (6)
Difference in Sniffin' Sticks test scores between the CFTR-MT cohort and Non-CFTR-MT cohort
Olfactory function will be tested using the Sniffin' Sticks extended test kit (MediSense, NL) using the established threshold, discrimination, and identification (TDI) scoring system. Threshold testing will be scored on a scale from 1 to 16 points. Discrimination scoring will be scored on a scale from 0-16 points. Identification will be scored on a scale from 0 to 16 points). A final Threshold, Discrimination, and Identification (TDI) score will be reported between 1-48. A higher score indicates better olfactory function, and a lower score indicates worse olfactory function.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in the University of Pennsylvania Smell Identification Test scores between the CFTR-MT cohort and Non-CFTR-MT cohort
Participants may be asked to complete the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is scored on a scale from 0-40, with a higher score indicating better olfaction.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Cystic Fibrosis Questionnaire-Revised survey responses between CFTR-MT cohort and Non-CFTR-MT cohort
Participants will be asked to complete the validated Cystic Fibrosis Questionnaire-Revised survey. This survey evaluates CF-specific and general QOL metrics and has robust psychometric properties and consistent associations with health outcomes.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Sino-nasal Outcome Test-22 (SNOT-22) survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Participants will be asked to complete the Sino-nasal Outcome Test-22 (SNOT-22) which is the most commonly used survey for evaluating outcomes in patients with CRS. This metric has been thoroughly validated, is widely employed, and is predictive of patient-perceived symptom control. The questionnaire has 5 domains with a total score ranging 0-110. A lower score indicates a lower severity of nasal disorder symptoms, and a higher score indicates a higher severity of nasal disorder symptoms.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Sinus Control Test survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Participants will be asked to complete the validated Sinus Control Test - a 4-question questionnaire that assesses disease control in chronic rhinosinusitis. This survey is scored on a scale of 0-20, with a lower score indicating higher control of sinus symptoms and a higher score indicating lower control of sinus symptoms.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Questionnaire of Olfactory Disorder survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Participants will be asked to complete the questionnaire of olfactory disorders (QOD). This is a validated survey used to assess the impact of olfactory dysfunction on patients with sinonasal disease. There are 25 questions in three domains which give information about the degree to which patients suffer from olfactory impairment. This survey is scored on a scale from 0-57 points. A higher score indicates greater olfactory impairment.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start8 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan.E.Little, Dartmouth-Hitchcock Medical Center
- Investigators
- Ryan E Little, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982795
- Sponsor's protocol ID
- STUDY02001953
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05982795
- Acronym / sponsor ID
- STUDY02001953
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does this therapy impact bacterial communities in the paranasal sinuses?
- How does this therapy impact inflammation in the paranasal sinuses and olfactory cleft?
- How does this therapy impact sense of smell and sinonasal disease burden in individuals with cystic fibrosis?
- 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.
Detailed description
The goal of this study is to characterize the effects of Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy on the sinonasal microbial communities and inflammatory profiles in adults with cystic fibrosis. Participants will be asked to complete the below research activities on a 6-month basis over the course of two years to total 5 research visits (0 months, 6 months, 12 months, 18 months, 24 months).
A mucus sample from the middle meatus will be obtained and stored at 4ºC until culture analysis. Semi-quantitative bacterial cultures will be performed. Bacterial community composition will be quantified using 16S rRNA variable region (V4) amplicon sequencing and qPCR. Data preprocessing and taxonomic assignment will be performed using QIIME 2 (v 2023.2) and the SILVA 138.1 rRNA database. Abundance data will be further processed in R (v 4.3.0) using packages decontam, phyloseq, and vegan.
Samples from the middle meatus and olfactory cleft will be analyzed to investigate the inflammatory profiles of patients with cystic fibrosis. Both samples will be centrifuged at 4°C, 10,000 rpm for 10 minutes to extract the entire sample from the material. Samples will be transferred by pipette to cryovials, flash-frozen in liquid nitrogen, and stored in a -80°C environment until time of laboratory assay. The study will assess changes in immune status through cytokine arrays. To assess innate immune responses, a Bioplex Pro Human Inflammation Assay for 37 human cytokines (BD Biosciences) will be employed.
The study will also investigate if alterations in nasal microbiome and inflammatory profile correlate with changes in cystic fibrosis-specific quality of life (QOL) and olfaction outcomes. Participants will be asked to complete olfactory function testing using the Sniffin' Sticks extended test kit (MediSense, NL) and/or the University of Pennsylvania Smell Identification Test (UPSIT). Additionally, participants will be asked to complete the four following surveys to assess their quality of life as it relates to sinus symptom severity, disease control, and sense of smell: Cystic Fibrosis Questionnaire-Revised, Sino-nasal Outcome Test-22, Sinus Control Test, and Questionnaire of Olfactory Disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFTR-MT Group | – | Other: Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge, Other: Olfactory Function Testing, Other: Survey CompletionThe 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 | – | Other: Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge, Other: Olfactory Function Testing, Other: Survey CompletionThe 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is adult, English-speaking cystic fibrosis patients being seen at the New Hampshire Cystic Fibrosis Center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Adults unable to consent
- Individuals who are not yet adults
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal endoscopy with microbiome swab and mucus collection through filter paper and spongeA 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. | Other | CFTR-MT Group, Non-CFTR-MT Group |
| Olfactory Function TestingOlfactory 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. | Other | CFTR-MT Group, Non-CFTR-MT Group |
| Survey CompletionParticipants 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. | Other | CFTR-MT Group, Non-CFTR-MT Group |
Primary outcome
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
Difference in microbial communities in mucus swabs between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not on CFTR-MT.
Difference in inflammatory profiles between CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in microbiome swab cytokine assay results between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not of CFTR-MT.
6 secondary outcomes
Difference in Sniffin' Sticks test scores between the CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in the University of Pennsylvania Smell Identification Test scores between the CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Cystic Fibrosis Questionnaire-Revised survey responses between CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Sino-nasal Outcome Test-22 (SNOT-22) survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Sinus Control Test survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Difference in Questionnaire of Olfactory Disorder survey scores between CFTR-MT cohort and Non-CFTR-MT cohort
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michaela M Geffert, BS contact
Ryan E Little, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan E Little, MD ((603) 650 8123, Ryan.E.Little@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.