Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine Solution
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/15/2019 |
| Start Date: | November 2012 |
| End Date: | July 27, 2017 |
Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation Solution
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.
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.
Inclusion Criteria:
- Documented diagnosis of cystic fibrosis
- Age 18 years old or greater
- FEV1 percent predicted greater than 25%
- Ability to perform reproducible pulmonary function tests and produce sputum
spontaneously
- Chronic bacterial colonization with Pseudomonas aeruginosa with 2 positive cultures in
previous 2 years.
- Chronically stable pulmonary condition without evidence of acute pulmonary
exacerbation within 14 days prior to screening
- Starting Cayston cycle as part of clinical care.
Exclusion Criteria:
- Presence of a condition or abnormality that, in the opinion of the Principal
Investigator (PI), would compromise the safety of the patient or the quality of the
data.
- Aztreonam allergy, bronchospasm or other contraindication to use of aztreonam.
- Signs and symptoms of acute pulmonary exacerbation at the time of enrollment or during
study.
- Active infection and treatment for non-tuberculous mycobacteria.
- Concomitant use of systemic steroids.
- Use of inhaled antimicrobial agents with activity against Pseudomonas aeruginosa
within 28 days prior to Visit 1.
We found this trial at
1
site
1400 Jackson St
Denver, Colorado 80206
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Milene Saavedra, MD
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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