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NCT04397861
T Cell Memory Fuels the Innate Response in Chronic CF Lung Disease
trial in Cystic Fibrosis in 112 participants. Completed in 1 November 2021.
1 May 2019
Quick facts
| Lead sponsor | National Jewish Health |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 112 |
| Start date | 6 May 2015 |
| Primary completion | 1 May 2019 |
| Estimated completion | 1 November 2021 |
| 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
This study seeks to define the role of CD4+ and CD8+ T cell memory responses in the immunologic failure of patients with cystic fibrosis (CF) to clear infections. In a normal host, the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection, in great part due to the recall and effector functions of memory T cells. In CF, far less is understood regarding the response of T cell memory when hosts reencounter antigens, otherwise known as pulmonary exacerbations. Pulmonary exacerbations are pivotal events that lead to a decline in health status among CF patients, with many never recovering to baseline health. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Following enrollment at the time of antibiotic initiation, blood will be collected at two different time points. The first samples will be collected within 24 hours of starting IV antibiotic therapy. The second blood specimen will be collected at the end of hospitalization, after a minimum of 5 days. At the time of each blood draw, complete blood counts, a sputum sample, and simple spirometry will be measured as part of the standard care of a CF exacerbation. Isolated PBMCs will be stained with antibodies to designate cell surface phenotype. They will then be sorted to identify the T cell population. These cells will be tested on their ability to clear pathogens. The relationship between cellular immune responses and clinical indicators of pulmonary status will be examined by fitting linear mixed models.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04397861
- Europe PMC full search
- ASCO Meeting Library
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Other National Jewish Health trials
Trials by the same sponsor.
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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 NCT04397861 (US National Library of Medicine, public domain)
- 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: 29 September 2022
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/NCT04397861.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing