Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine Solution
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Purpose
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.
| Condition |
|---|
|
Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation Solution |
- Gene biomarker panel [ Time Frame: 1 month ] [ Designated as safety issue: No ]Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in pulmonary function (FEV1) after one month of Cayston therapy
- Sputum Bacterial Density [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in sputum bacterial density after one month of Cayston
- C-reactive protein [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in C-reactive protein after one month of Cayston
- Interleukin 8 [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in serum and sputum interleukin 8 concentrations after one month of Cayston
- Patient reported symptom scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in patient reported symptoms after one month of Cayston
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| CF adults colonized with Pseudomonas aeruginosa |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 a 6 month period off of Cayston.
Inclusion Criteria:
- Documented diagnosis of cystic fibrosis
- Age 18 years old or greater
- FEV1 percent predicted between 25%-75%
- Ability to perform reproducible pulmonary function tests and produce sputum spontaneously
- Chronic bacterial colonization with Pseudomonas aeruginosa
- Chronically stable pulmonary condition without evidence of acute pulmonary exacerbation within 14 days prior to screening
- No use of inhaled Cayston in the 6 months prior to enrollment.
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.
- Use of inhaled Cayston in the 6 months prior to enrollment.
- 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.
Contacts and Locations| Contact: Katie Poch | pochk@njhealth.org |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Katie Poch, BS pochk@njhealth.org | |
| Principal Investigator: Milene Saavedra, MD | |
| Sub-Investigator: Jerry Nick, MD | |
More Information
No publications provided
| Responsible Party: | National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT01736839 History of Changes |
| Other Study ID Numbers: | IN-US-205-0171 |
| Study First Received: | November 15, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Inflammation Pseudomonas Infections Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections Aztreonam Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013