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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Jewish Health
Sponsor:
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01736839
First received: November 15, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736839

Contacts
Contact: Katie Poch pochk@njhealth.org

Locations
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         
Sponsors and Collaborators
National Jewish Health
  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
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014