Last reviewed · How we verify
NCT04353752
Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs
trial in Cystic Fibrosis in 58 participants. Completed in 26 July 2023.
12 January 2021
Quick facts
| Lead sponsor | National Jewish Health |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 58 |
| Start date | 16 September 2019 |
| Primary completion | 12 January 2021 |
| Estimated completion | 26 July 2023 |
| Sites | 1 location across United States |
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
National Jewish Health — full company profile →
Who can join
18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
CF patients enrolled in this protocol will be recruited from patients followed by the Adult CF Program at National Jewish Health. Patients will be selected based on planned use of a CFTR modulator by their primary physician. No patient will be started on (or will switch) CFTR modulator agents for the purpose of the study. After enrollment, biological samples may be collected at two different time points prior to treatment initiation. One set of samples will be collected at baseline health prior to CFTR modulator initiation or change. A second set of samples will be obtained in subjects at the time of acute pulmonary exacerbation, if one occurs prior to CFTR modulator initiation or change. Post CFTR modulator initiation study assessments will be obtained at least one month after starting treatment and continue up to 2 times a year (including during pulmonary exacerbations), in order to document longitudinal effects of therapies and changes in inflammatory biology over time. At the time of each biological sampling, blood, sputum sample, urine, and a quality of life assessment will be acquired in all enrolled subjects. In addition to demographic data, clinical data, such as quantitative microbiology and simple spirometry will be recorded at the time of sample collection.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2
Verify or expand the search:
- PubMed search for NCT04353752
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Jewish Health trials
Trials by the same sponsor.
- NCT06435520 — Enhancing Hypnotic Medication Discontinuation in Primary Care · Phase 4 · recruiting
- NCT06262282 — Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria · enrolling by invitation
- NCT06155747 — Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt) · recruiting
- NCT04724278 — Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study · unknown
- NCT05313087 — COVID-19 Vaccine Response in Chronic Respiratory Conditions · unknown
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 NCT04353752 (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 National Jewish Health
- Last refreshed: 13 April 2026
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/NCT04353752.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing