Denver, Colorado 80206

  • Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa

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.


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.


Study is Available At:


Original ID:

IN-US-205-0171


NCT ID:

NCT01736839


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Jewish Health


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

23


Enrollment Type:

Actual


Study Dates

Start Date:November 2012
Completion Date:July 27, 2017
Completion Type:Actual
Primary Completion Date:July 27, 2017
Primary Completion Type:Actual
Verification Date:March 2020
Last Changed Date:March 20, 2020
First Received Date:November 15, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient reported symptom scores
Time Frame:1 month
Safety Issues:False
Description:Change in patient reported symptoms after one month of Cayston
Outcome Type:Secondary Outcome
Measure:Interleukin 8
Time Frame:1 month
Safety Issues:False
Description:Change in serum and sputum interleukin 8 concentrations after one month of Cayston
Outcome Type:Secondary Outcome
Measure:C-reactive protein
Time Frame:1 month
Safety Issues:False
Description:Change in C-reactive protein after one month of Cayston
Outcome Type:Secondary Outcome
Measure:Sputum Bacterial Density
Time Frame:1 month
Safety Issues:False
Description:Change in sputum bacterial density after one month of Cayston
Outcome Type:Secondary Outcome
Measure:Forced expiratory volume in 1 second (FEV1)
Time Frame:1 month
Safety Issues:False
Description:Change in pulmonary function (FEV1) after one month of Cayston therapy
Outcome Type:Primary Outcome
Measure:Gene biomarker panel
Time Frame:1 month
Safety Issues:False
Description:Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:CF adults colonized with Pseudomonas aeruginosa

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:National Jewish Health

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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