Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas AeruginosaNCT01736839
Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine Solution
An observational study of Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa, run by National Jewish Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 27 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF adults colonized with Pseudomonas aeruginosa | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene biomarker panel
Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy
Measured: 1 month
Secondary outcomes (5)
Forced expiratory volume in 1 second (FEV1)
Change in pulmonary function (FEV1) after one month of Cayston therapy
Measured: 1 month
Sputum Bacterial Density
Change in sputum bacterial density after one month of Cayston
Measured: 1 month
C-reactive protein
Change in C-reactive protein after one month of Cayston
Measured: 1 month
Interleukin 8
Change in serum and sputum interleukin 8 concentrations after one month of Cayston
Measured: 1 month
Patient reported symptom scores
Change in patient reported symptoms after one month of Cayston
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas AeruginosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736839
- Sponsor's protocol ID
- IN-US-205-0171
- Status last verified
- Mar 2020
- First submitted
- 15 Nov 2012
- Last updated
- 24 Mar 2020
- Results posted
- No
Publications
Caceres SM, Sanders LA, Rysavy NM, Poch KR, Jones CR, Pickard K, Fingerlin TE, Marcus RA, Malcolm KC, Taylor-Cousar JL, Nichols DP, Nick JA, Strand M, Saavedra MT. Blood mRNA biomarkers distinguish variable systemic and sputum inflammation at treatment initiation of inhaled antibiotics in cystic fibrosis: A prospective non-randomized trial. PLoS One. 2022 May 5;17(5):e0267592. doi: 10.1371/journal.pone.0267592. eCollection 2022.
PubMed 35511761
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation Solution
- ClinicalTrials.gov ID
- NCT01736839
- Acronym / sponsor ID
- IN-US-205-0171
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF adults colonized with Pseudomonas aeruginosa | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene biomarker panel
Time frame: 1 month
Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy
5 secondary outcomes
Forced expiratory volume in 1 second (FEV1)
Time frame: 1 month
Sputum Bacterial Density
Time frame: 1 month
C-reactive protein
Time frame: 1 month
Interleukin 8
Time frame: 1 month
Patient reported symptom scores
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 35511761Caceres SM, Sanders LA, Rysavy NM, Poch KR, Jones CR, Pickard K, Fingerlin TE, Marcus RA, Malcolm KC, Taylor-Cousar JL, Nichols DP, Nick JA, Strand M, Saavedra MT. Blood mRNA biomarkers distinguish variable systemic and sputum inflammation at treatment initiation of inhaled antibiotics in cystic fibrosis: A prospective non-randomized trial. PLoS One. 2022 May 5;17(5):e0267592. doi: 10.1371/journal.pone.0267592. eCollection 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene biomarker panel (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.