Skip to main content
OpenTrials
Completed

NCT Number: NCT01736839

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Gene biomarker panel

    Time frame: 1 month

    Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy

Secondary outcomes

  1. Forced expiratory volume in 1 second (FEV1)

    Time frame: 1 month

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

  2. Sputum Bacterial Density

    Time frame: 1 month

    Change in sputum bacterial density after one month of Cayston

  3. C-reactive protein

    Time frame: 1 month

    Change in C-reactive protein after one month of Cayston

  4. Interleukin 8

    Time frame: 1 month

    Change in serum and sputum interleukin 8 concentrations after one month of Cayston

  5. Patient reported symptom scores

    Time frame: 1 month

    Change in patient reported symptoms after one month of Cayston

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2012
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.