An observational study in Cystic Fibrosis (CF) and Type 2 Inflammatory Disorders, sponsored by University of Virginia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Virginia · Observational
The goal of this observational study is to better understand why some adults with cystic fibrosis (CF) continue to have repeated pulmonary exacerbations, or episodes of worsening respiratory symptoms, despite treatment with highly effective CFTR modulator therapy. The study will focus on whether a type of inflammation called type 2 (T2) inflammation may contribute to these pulmonary exacerbations.
The main questions this study aims to answer are:
Are signs of T2 inflammation more common in adults with CF who have frequent pulmonary exacerbations?
Are there differences in inflammation in the nose and airways between people who have frequent pulmonary exacerbations and those who do not?
How do immune cells and inflammation change during a pulmonary exacerbation?
Participants will:
Allow researchers to collect information about their CF and pulmonary exacerbations from their medical records.
Complete questionnaires about respiratory and sinus symptoms and quality of life.
Provide research blood samples, samples from inside the nose, and exhaled breath condensate.
Be followed for up to approximately 3 years, with additional research samples collected during qualifying pulmonary exacerbations when feasible.
Participants will continue to receive their usual CF medical care. No experimental medications or treatments will be given as part of this study.
This prospective observational study will investigate the relationship between type 2 (T2) inflammation and recurrent pulmonary exacerbations in adults with cystic fibrosis (CF) who are receiving highly effective CFTR modulator therapy. Participants will undergo longitudinal clinical follow-up and research biospecimen collection for up to approximately three years.
After at least 24 months of prospective observation, participants will be classified according to their pulmonary exacerbation frequency. Participants averaging two or more qualifying pulmonary exacerbations per year will be classified as having modulator-refractory CF, while those averaging fewer than two qualifying pulmonary exacerbations per year will be classified as having modulator-responsive CF. This classification will be based on prospectively observed exacerbations rather than exacerbation history before enrollment.
The study will evaluate whether participants with modulator-refractory CF demonstrate evidence of persistent T2 inflammation during stable disease. Clinical and blood-based inflammatory characteristics will be assessed, including peripheral blood eosinophils. Airway inflammation will be characterized using nasal epithelial cells and nasal lining fluid, including assessment of gene-expression patterns and soluble inflammatory mediators. Exhaled breath condensate will also be evaluated as an exploratory source of airway inflammatory biomarkers.
For participants who experience qualifying pulmonary exacerbations, additional biospecimens may be collected when feasible without delaying or altering clinically indicated treatment. Paired blood samples collected during stable disease and pulmonary exacerbations will be used to evaluate changes in circulating immune-cell populations, including activated T-helper type 2 (Th2) cells.
The study is observational. Treatment decisions, including treatment of pulmonary exacerbations, will be made by the participant's clinical care team and will not be determined by the research protocol.
1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's planned enrollment of 100 is above the median of 85 across 489 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults with cystic fibrosis receiving highly effective CFTR modulator therapy who receive care through the University of Virginia Adult Cystic Fibrosis Program. Participants will be enrolled while clinically stable and followed prospectively for up to approximately 3 years to characterize pulmonary exacerbations and inflammatory phenotypes. After 24 months of prospective observation, participants will be classified according to pulmonary exacerbation frequency for study analyses.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Baseline Stable-State Absolute Peripheral Blood Eosinophil Count
Absolute peripheral blood eosinophil count measured during clinical stability at baseline. Eosinophil counts will be compared between participants who, after 36 months of prospective observation, are classified as having modulator-refractory CF (average of ≥2 qualifying pulmonary exacerbations per year) or modulator-responsive CF (average of \<2 qualifying pulmonary exacerbations per year).
Time frame: Baseline
Change in Nasal Epithelial Gene Expression from Baseline to Pulmonary Exacerbation
Within-participant changes in nasal epithelial gene expression from stable-state baseline to qualifying pulmonary exacerbations will be evaluated using RNA sequencing. Exploratory analyses will characterize changes in gene-expression patterns associated with type 2 inflammation and recurrent pulmonary exacerbations in adults with cystic fibrosis.
Time frame: Baseline and qualifying pulmonary exacerbations occurring up to Month 36.
Change in Exhaled Breath Condensate Inflammatory Mediator Concentrations from Baseline to Pulmonary Exacerbation
Within-participant changes in inflammatory mediator concentrations in exhaled breath condensate will be evaluated between stable-state baseline and qualifying pulmonary exacerbations. These analyses will explore noninvasive biomarkers of airway inflammation and their association with changes in clinical state.
Time frame: Baseline and qualifying pulmonary exacerbations occurring up to Month 36.
Change in Peripheral Blood Immune Cell Phenotypes from Baseline to Pulmonary Exacerbation
Within-participant changes in peripheral blood immune-cell populations from stable-state baseline to qualifying pulmonary exacerbations will be characterized using high-dimensional flow cytometry. Analyses will emphasize changes in the frequency of CRTH2-positive CD4-positive Th2 effector cells, with exploratory characterization of additional immune-cell populations associated with type 2 inflammation.
Time frame: Baseline and qualifying pulmonary exacerbations occurring up to Month 36.
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying results reported in publications from this study may be shared, along with relevant supporting documentation, following publication and upon reasonable request. Access will be subject to applicable institutional, IRB, consent, and data-sharing requirements.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: De-identified IPD and supporting information will be available beginning after publication of the primary study results and will remain available for at least 5 years following publication.
Access criteria: De-identified individual participant data underlying the published results may be made available to qualified researchers with a methodologically sound research proposal. Requests will be reviewed by the Principal Investigator and, as applicable, the University of Virginia. Data will be shared only to the extent permitted by participant consent, IRB requirements, institutional policies, and applicable data-sharing agreements. Requests may be directed to the Principal Investigator.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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