Cystic FibrosisNCT02056132
Breath Condensate Study in Patients With Cystic Fibrosis.
An observational study of Cystic Fibrosis, run by University of Florida at 1 site in United States.
Trial summary
There is an urgent need for a noninvasive method to diagnose bronchial infections and exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage (BAL). However, some patients cannot produce sputum. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exhaled Breath Condensate
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 22 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with Cystic Fibrosis.
Who may be able to join
- Any patient with Cystic Fibrosis (CF) in the age range 18-65 years who is known to be chronically infected in their respiratory tract will be eligible as cases. Any other patient or healthy subject in the age range 18-65 years who is not infected with Pseudomonas in their respiratory tract will be eligible as controls.
Who cannot join
- Any study subject, who cannot co-operate with the study, cannot co-ordinate breathing or cannot breathe through a mouthpiece.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exhaled Breath Condensate for Evaluation of Lung Infections and Exacerbations in Patient With Cystic Fibrosis.
There is an urgent need for a noninvasive method to diagnose bronchial infections and exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage (BAL). However, some patients cannot produce sputum. At the same time the decision of when a patient has an exacerbation continues to be very subjective. In this exploratory study, we propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible markers of inflammation that can assist in a noninvasive way in the determination of exacerbations.
Read the detailed description
We hypothesize that it is possible to recover microbial products causing infections in Exhaled Breath Condensate (EBC) samples as well as to measure markers of inflammation like Interleukin (IL)-8, Leukotriene B4 (LTB4), Interleukin IL-6, Interleukin IL-1B, Tumor Necrosis Factor alpha, as well as proteases like neutrophil elastase, matrix metalloproteinase 2 and 9 and antiproteases like secretory leukoprotease inhibitor (SLPI), alpha one antitrypsin and tissue inhibitor of metalloproteinase-1 (TIMP-1). As a way to compare our findings to systemic inflammation we will also measure C-reactive protein in serum.
20 patients with cystic fibrosis who have chronic bronchial infection and 20 controls will be recruited. Their exhaled breath condensate and sputum samples will be collected and analyzed for the presence of bacteria through traditional, molecular and nuclear acid amplification methods as well as Pyrosequencing analysis. We will also measure the above markers of inflammation and follow the CF patients for the following year so we can continue to collect exhaled breath condensate when they have an exacerbation and are admitted to the hospital as well as after treatment for the exacerbation. We will correlate these markers with patient's clinical features including pulmonary function test, Body max index, CF pathogens, and CF genotype. If our hypothesis turns out to be true it will open up a possibility for a new noninvasive diagnostic and follow up method that will benefit cystic fibrosis patients.
- Hypothesis \& Specific Aims:
- Microbial products can be recovered from exhaled breath condensate. B. That these microbial products recovered from exhaled breath correlate with that recovered from sputum C. Markers of inflammation can be recovered from exhale breath condensate.
- Conditions
- Cystic Fibrosis
- Being tested
- Exhaled Breath Condensate
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled Breath CondensateOther
Lab results of Exhaled Breath Condensate
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis patients. | Patients with Cystic Fibrosis. Results of Exhaled Breath Condensate lab. Receives: Other: Exhaled Breath Condensate | |
| Control Subjects | Individuals without Cystic Fibrosis or signs of current respiratory infection. Results of Exhaled Breath Condensate lab. Receives: Other: Exhaled Breath Condensate |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of EBC finding with exacerbations.
Measured: 1 year
Secondary outcomes (1)
ability to identify common airway pathogens on EBC.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Lascano, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056132
- Sponsor's protocol ID
- IRB201200137
- Status last verified
- Aug 2023
- First submitted
- 4 Feb 2014
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate for Evaluation of Lung Infections and Exacerbations in Patient With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT02056132
- Acronym / sponsor ID
- IRB201200137
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 5 Feb 2014 (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.
There is an urgent need for a noninvasive method to diagnose bronchial infections and exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage (BAL). However, some patients cannot produce sputum. At the same time the decision of when a patient has an exacerbation continues to be very subjective. In this exploratory study, we propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible markers of inflammation that can assist in a noninvasive way in the determination of exacerbations.
Detailed description
We hypothesize that it is possible to recover microbial products causing infections in Exhaled Breath Condensate (EBC) samples as well as to measure markers of inflammation like Interleukin (IL)-8, Leukotriene B4 (LTB4), Interleukin IL-6, Interleukin IL-1B, Tumor Necrosis Factor alpha, as well as proteases like neutrophil elastase, matrix metalloproteinase 2 and 9 and antiproteases like secretory leukoprotease inhibitor (SLPI), alpha one antitrypsin and tissue inhibitor of metalloproteinase-1 (TIMP-1). As a way to compare our findings to systemic inflammation we will also measure C-reactive protein in serum.
20 patients with cystic fibrosis who have chronic bronchial infection and 20 controls will be recruited. Their exhaled breath condensate and sputum samples will be collected and analyzed for the presence of bacteria through traditional, molecular and nuclear acid amplification methods as well as Pyrosequencing analysis. We will also measure the above markers of inflammation and follow the CF patients for the following year so we can continue to collect exhaled breath condensate when they have an exacerbation and are admitted to the hospital as well as after treatment for the exacerbation. We will correlate these markers with patient's clinical features including pulmonary function test, Body max index, CF pathogens, and CF genotype. If our hypothesis turns out to be true it will open up a possibility for a new noninvasive diagnostic and follow up method that will benefit cystic fibrosis patients.
- Hypothesis \& Specific Aims:
- Microbial products can be recovered from exhaled breath condensate. B. That these microbial products recovered from exhaled breath correlate with that recovered from sputum C. Markers of inflammation can be recovered from exhale breath condensate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis patients. | – | Other: Exhaled Breath CondensatePatients with Cystic Fibrosis. Results of Exhaled Breath Condensate lab. |
| Control Subjects | – | Other: Exhaled Breath CondensateIndividuals without Cystic Fibrosis or signs of current respiratory infection. Results of Exhaled Breath Condensate lab. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Cystic Fibrosis.
Key inclusion criteria (1 listed)
- Any patient with Cystic Fibrosis (CF) in the age range 18-65 years who is known to be chronically infected in their respiratory tract will be eligible as cases. Any other patient or healthy subject in the age range 18-65 years who is not infected with Pseudomonas in their respiratory tract will be eligible as controls.
Key exclusion criteria (1 listed)
- Any study subject, who cannot co-operate with the study, cannot co-ordinate breathing or cannot breathe through a mouthpiece.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled Breath CondensateLab results of Exhaled Breath Condensate | Other | Control Subjects, Cystic Fibrosis patients. |
Primary outcome
correlation of EBC finding with exacerbations.
Time frame: 1 year
1 secondary outcome
ability to identify common airway pathogens on EBC.
Time frame: 1 year
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 25 Aug 2023.
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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.
Jorge Lascano, MD principal investigator
University of Florida
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, run by University of Florida 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 1 inclusion and 1 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 25 Aug 2023. 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?
correlation of EBC finding with exacerbations. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2023.