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

This study is currently recruiting participants.
Verified September 2016 by National Jewish Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736839
First Posted: November 29, 2012
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Jewish Health
  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 ]
    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)
Groups/Cohorts
CF adults colonized with Pseudomonas aeruginosa

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01736839     History of Changes
Other Study ID Numbers: IN-US-205-0171
First Submitted: November 15, 2012
First Posted: November 29, 2012
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Fibrosis
Inflammation
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
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents