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NCT03350828: CHEC-SC
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
trial in Cystic Fibrosis in 5,000 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | Nicole Hamblett |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 15 January 2018 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 52 locations across United States |
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Nicole Hamblett
Who can join
4 Months and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
PROMISE: Working with the CF community to understand emerging clinical and research needs for those treated with highly effective CFTR modulator therapy.
Nichols DP, Donaldson SH, Frederick CA, Freedman SD, et al · · 2021 · cited 68× · PMID 33619012 · DOI 10.1016/j.jcf.2021.02.003 -
Heterogeneity of CFTR modulator-induced sweat chloride concentrations in people with cystic fibrosis.
Zemanick ET, Emerman I, McCreary M, Mayer-Hamblett N, et al · · 2024 · cited 18× · PMID 38360461 · DOI 10.1016/j.jcf.2024.02.001 -
Measuring the impact of CFTR modulation on sweat chloride in cystic fibrosis: Rationale and design of the CHEC-SC study.
Zemanick ET, Konstan MW, VanDevanter DR, Rowe SM, et al · · 2021 · cited 16× · PMID 33573995 · DOI 10.1016/j.jcf.2021.01.011 -
Characterizing CFTR modulated sweat chloride response across the cf population: Initial results from the CHEC-SC study.
Mayer-Hamblett N, Zemanick ET, Odem-Davis K, VanDevanter D, et al · · 2023 · cited 7× · PMID 35871974 · DOI 10.1016/j.jcf.2022.07.008 -
Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials.
VanDevanter DR, Zemanick ET, Konstan MW, Ren CL, et al · · 2023 · cited 4× · PMID 37100705 · DOI 10.1016/j.jcf.2023.04.007 -
Impact of CFTR Modulator Concentrations on Clinical Response in Cystic Fibrosis.
Chalamalla AR, Baker E, Ryan KJ, Dowell A, et al · · 2026 · PMID 41713946 · DOI 10.1183/13993003.01594-2025
Verify or expand the search:
- PubMed search for NCT03350828
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cystic Fibrosis
Currently open trials in the same condition.
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- NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
- NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
- NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting
Other Nicole Hamblett trials
Trials by the same sponsor.
- NCT06504589 — A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators · recruiting
- NCT04613128 — The PROMISE Pediatric Study 6 to 11 Years Old · active not recruiting
- NCT06350474 — Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study · NA · completed
- NCT06350461 — Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study · NA · completed
- NCT04378153 — Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03350828 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nicole Hamblett
- Last refreshed: 10 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03350828.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing