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In cystic fibrosis, there is a critical need for better predictors of treatment response. The investigators have identified a panel of white blood cell biomarkers which can be directly measured as a blood test in subjects with cystic fibrosis. These biomarkers predict reduction of airway inflammation and infection more accurately than lung function testing, in patients receiving intravenous antibiotic therapy. In the current study, we hypothesize that this panel of gene biomarkers which can be readily measured from peripheral blood will sensitively predict changes in inflammation when patients receive inhaled antibiotic therapy, specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study will have blood drawn before and after a month of inhaled Cayston, in order to test whether genes predict response to Cayston therapy more robustly than do standard measures such as lung function tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF adults colonized with Pseudomonas aeruginosa |
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| Measure | Description | Time Frame |
|---|---|---|
| Gene biomarker panel | Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) | Change in pulmonary function (FEV1) after one month of Cayston therapy | 1 month |
| Sputum Bacterial Density | Change in sputum bacterial density after one month of Cayston |
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Inclusion Criteria:
Exclusion Criteria:
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Enrolled subjects will include adults with cystic fibrosis, over the age of 18 years, who are at baseline health and colonized with Pseudomonas aeruginosa, and who are newly prescribed Cayston (aztreonam lysine) for inhalation, or who are resuming use of this drug after 28 days off of inhaled antimicrobial agents with activity against Pseudomonas aeruginosa.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35511761 | Derived | Caceres SM, Sanders LA, Rysavy NM, Poch KR, Jones CR, Pickard K, Fingerlin TE, Marcus RA, Malcolm KC, Taylor-Cousar JL, Nichols DP, Nick JA, Strand M, Saavedra MT. Blood mRNA biomarkers distinguish variable systemic and sputum inflammation at treatment initiation of inhaled antibiotics in cystic fibrosis: A prospective non-randomized trial. PLoS One. 2022 May 5;17(5):e0267592. doi: 10.1371/journal.pone.0267592. eCollection 2022. |
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| 1 month |
| C-reactive protein | Change in C-reactive protein after one month of Cayston | 1 month |
| Interleukin 8 | Change in serum and sputum interleukin 8 concentrations after one month of Cayston | 1 month |
| Patient reported symptom scores | Change in patient reported symptoms after one month of Cayston | 1 month |