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Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine Solution

Information source: National Jewish Health
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa

Phase: N/A

Status: Recruiting

Sponsored by: National Jewish Health

Overall contact:
Katie Poch, Email: pochk@njhealth.org

Summary

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.

Clinical Details

Official title: Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation Solution

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Gene biomarker panel

Secondary outcome:

Forced expiratory volume in 1 second (FEV1)

Sputum Bacterial Density

C-reactive protein

Interleukin 8

Patient reported symptom scores

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Katie Poch, Email: pochk@njhealth.org

National Jewish Health, Denver, Colorado 80206, United States; Recruiting
Katie Poch, BS, Email: pochk@njhealth.org
Milene Saavedra, MD, Principal Investigator
Jerry Nick, MD, Sub-Investigator
Additional Information

Starting date: November 2012
Last updated: April 14, 2015

Page last updated: August 20, 2015

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