Cystic FibrosisIMPACTNCT04735952
Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
An observational study of Cystic Fibrosis, run by University of British Columbia at 7 sites in 2 countries.
Trial summary
The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 300 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 3 May 2019to 31 Dec 2024
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will have a diagnosis of cystic fibrosis with cultures that are either P. aeruginosa (Pa) negative or Pa positive.
Who may be able to join
- Aim 1, Cross-Sectional
- IInclusion Criteria:
- Male or female, ages 8 years and older
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
- @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
- FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
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- Either P. aeruginosa (Pa) negative or chronically infected with P. aeruginosa (Pa positive) as defined below:
- P. aeruginosa negative: must meet one of the following criteria: i: No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures, OR ii: No history of Pa positive airway cultures (sputum, OP, Bronchoalveolar lavage) b. P. aeruginosa positive i: Over 50% of cultures positive and at least 2 cultures positive for Pa in previous 18 months
- Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.
- Male or female, ages 8-16 years
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
- @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
- FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
- P. aeruginosa negative, based on one of the following criteria:
- No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
- No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage)
- Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.
- Male or female, ages 3-8 years
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations 3. FEV1 ≥ 30%
- 4. Unable to expectorate sputum 5. P. aeruginosa negative, based on one of the following criteria:
- No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
- No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage) 6. Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.
Who cannot join
- Age < 8 years
- Intermittently infected with Pa
- FEV1 < 30%
- History of lung transplant
- Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
- Aim 2, Longitudinal
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- Age < 8 years
- Intermittently or chronically infected with Pa
- Unable to expectorate sputum or undergo sputum induction
- FEV1 < 30%
- History of lung transplant
- Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
- Age < 3 years
- Intermittently or chronically infected with Pa
- FEV1 < 30%
- History of lung transplant
- Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites, 1 recruiting
- Completed
Children's Hospital Colorado
Aurora, Colorado, 80045
- Completed
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039
- Completed
National Jewish Health
Denver, Colorado, 80206
- Not yet recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Brian O'Sullivan, MD, Brian.P.O'Sullivan@hitchcock.org
Kathy Phipps, BA, 8026839291, kathy.j.phipps@dartmouth.edu
- Completed
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Canada2 sites, 2 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H3N1
Jonathan Rayment, MD, 604-875-2345, Jonathan.Rayment@bcchr.ca
Alam Lakhani, Alam.Lakhani@cw.bc.ca
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Bradley Quon, MD, 604-787-3536, bradley.quon@hli.ubc.ca
About this study
The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Sputum, induced sputum, and oropharyngeal swabs will be collected and evaluated at each clinic as part of standard clinical practice. Excess sputum will be sent to Children's Colorado Hospital for molecular analysis. No swabs will be sent anywhere (other than the clinic from which they originate). Breath samples will be taken from all study participants.
Read the detailed description
AIM 1: Refine and validate volatile biomarkers in the breath of adult and pediatric CF patients for detecting established P. aeruginosa lung infections. For each expectorating subject (n ≥ 288; 5 centers), the diagnostic accuracy of the volatile biomarker panel will be tested, with sputum culture as the standard.
AIM 2: Quantify intra-subject breath variability of the target pediatric population. We will collect longitudinal breath samples for two years from P. aeruginosa-negative subjects (n ≥ 58; ~60% non-expectorating) at 4 pediatric CF clinical centers. We will measure intra-subject variance in the breath signatures of expectorating and non-expectorating subjects, with the latter being the target population for the clinical trial. Two to 8 breath samples will be collected per patient.
- Conditions
- Cystic Fibrosis
- Keywords
- Breath, IMPACT
- Medical subject headings
- Cystic Fibrosis, Tooth, Impacted
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 |
|---|---|---|
| AIM 1 | No-Intervention. Participants in this group will have 1 study visit only. During that visit, breath and sputum samples will be collected. | |
| AIM 2 | No-Intervention. Participants in this group will have up to 8 study visits over a 2 year period. During the study visits, breath and sputum samples will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples obtained from persons with and without P. aeruginosa lung infections
Measured using comprehensive two-dimensional gas chromatography of exhaled breath compared to sputum culture (gold standard)
Measured: Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment
Secondary outcomes (1)
Intra-subject changes in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples
Breath samples obtained over a duration of two years, measured using comprehensive two-dimensional gas chromatography of exhaled breath
Measured: Thru end of 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 May 2019
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 British ColumbiaThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Children's Hospital Colorado, National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Jane Hill, PhD, University of British Columbia
- Investigators
- Jane E Hill, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735952
- Sponsor's protocol ID
- 331178/ H20-00071
- Other IDs
- Pro00043176, HILL18A0, R56HL139846
- Acronym
- IMPACT
- Status last verified
- Dec 2023
- First submitted
- 21 Jan 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
- ClinicalTrials.gov ID
- NCT04735952
- Acronym / sponsor ID
- IMPACT / 331178/ H20-00071
- Conditions
- Cystic Fibrosis
- Keywords
- Breath, IMPACT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Arizona State University, Children's Hospital Colorado, National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation
- Study start
- 3 May 2019 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Feb 2021 (actual)
- 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.
The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Sputum, induced sputum, and oropharyngeal swabs will be collected and evaluated at each clinic as part of standard clinical practice. Excess sputum will be sent to Children's Colorado Hospital for molecular analysis. No swabs will be sent anywhere (other than the clinic from which they originate). Breath samples will be taken from all study participants.
Detailed description
AIM 1: Refine and validate volatile biomarkers in the breath of adult and pediatric CF patients for detecting established P. aeruginosa lung infections. For each expectorating subject (n ≥ 288; 5 centers), the diagnostic accuracy of the volatile biomarker panel will be tested, with sputum culture as the standard.
AIM 2: Quantify intra-subject breath variability of the target pediatric population. We will collect longitudinal breath samples for two years from P. aeruginosa-negative subjects (n ≥ 58; ~60% non-expectorating) at 4 pediatric CF clinical centers. We will measure intra-subject variance in the breath signatures of expectorating and non-expectorating subjects, with the latter being the target population for the clinical trial. Two to 8 breath samples will be collected per patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM 1 | – | –No-Intervention. Participants in this group will have 1 study visit only. During that visit, breath and sputum samples will be collected. |
| AIM 2 | – | –No-Intervention. Participants in this group will have up to 8 study visits over a 2 year period. During the study visits, breath and sputum samples will be collected. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will have a diagnosis of cystic fibrosis with cultures that are either P. aeruginosa (Pa) negative or Pa positive.
Key inclusion criteria (22 listed)
- Aim 1, Cross-Sectional
- Male or female, ages 8 years and older
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
- @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
- FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
Key exclusion criteria (17 listed)
- Age < 8 years
- Intermittently infected with Pa
- FEV1 < 30%
- History of lung transplant
- Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
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
Differences in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples obtained from persons with and without P. aeruginosa lung infections
Time frame: Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment
Measured using comprehensive two-dimensional gas chromatography of exhaled breath compared to sputum culture (gold standard)
1 secondary outcome
Intra-subject changes in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples
Time frame: Thru end of 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Public access to study information and clinical site portal.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jane E Hill, PhD principal investigator
University of British Columbia
7 sites in 2 countries: 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 British Columbia at 7 sites in 2 countries.
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 22 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane E Hill, PhD (778 879 5105, jane.hill@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples obtained from persons with and without P. aeruginosa lung infections (time frame: Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment). 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 5 Dec 2023.