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

This study is currently recruiting participants.
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Verified September 2016 by National Jewish Health
Information provided by (Responsible Party):
National Jewish Health Identifier:
First received: November 15, 2012
Last updated: September 26, 2016
Last verified: September 2016
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.

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 ]
    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 ]
    Change in pulmonary function (FEV1) after one month of Cayston therapy

  • Sputum Bacterial Density [ Time Frame: 1 month ]
    Change in sputum bacterial density after one month of Cayston

  • C-reactive protein [ Time Frame: 1 month ]
    Change in C-reactive protein after one month of Cayston

  • Interleukin 8 [ Time Frame: 1 month ]
    Change in serum and sputum interleukin 8 concentrations after one month of Cayston

  • Patient reported symptom scores [ Time Frame: 1 month ]
    Change in patient reported symptoms after one month of Cayston

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
CF adults colonized with Pseudomonas aeruginosa


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 28 days off of inhaled antimicrobial agents with activity against Pseudomonas aeruginosa.

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.
  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 identifier: NCT01736839

Contact: Katie Poch

United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Katie Poch, BS   
Principal Investigator: Milene Saavedra, MD         
Sub-Investigator: Jerry Nick, MD         
Sponsors and Collaborators
National Jewish Health
  More Information

Responsible Party: National Jewish Health Identifier: NCT01736839     History of Changes
Other Study ID Numbers: IN-US-205-0171
Study First Received: November 15, 2012
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on June 23, 2017