Improving detection of lung infections in cystic fibrosis using breath samples

Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)

This study is testing if breath samples can help detect lung infections caused by Pseudomonas aeruginosa in people with cystic fibrosis.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 7 sites (Phoenix, Arizona and 6 other locations)
• Trial ID: NCT04735952 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate breath biomarkers for detecting Pseudomonas aeruginosa lung infections in patients with cystic fibrosis. It will enroll approximately 300 participants across five clinical sites in the USA, collecting breath samples alongside standard clinical sputum tests. The study will also assess breath variability in pediatric patients over two years, focusing on both expectorating and non-expectorating subjects. The goal is to enhance diagnostic accuracy and understanding of breath signatures in cystic fibrosis.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 8 years and older with a confirmed diagnosis of cystic fibrosis.

Not a fit: Patients without a diagnosis of cystic fibrosis or those with severe respiratory conditions unrelated to cystic fibrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and non-invasive methods for detecting lung infections in cystic fibrosis patients.

How similar studies have performed: Other studies have shown promise in using breath analysis for diagnosing lung infections, but this specific approach is novel in the context of cystic fibrosis.

Eligibility criteria

Inclusion Criteria:

* Aim 1, Cross-Sectional

IInclusion Criteria:

1. Male or female, ages 8 years and older
2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
3. @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
4. FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
5. Either P. aeruginosa (Pa) negative or chronically infected with P. aeruginosa (Pa positive) as defined below:

   a. 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
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.

Exclusion criteria:

1. Age \< 8 years
2. Intermittently infected with Pa
3. FEV1 \< 30%
4. History of lung transplant
5. 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

Inclusion Criteria, Expectorating Cohort (n=48):

1. Male or female, ages 8-16 years
2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
3. @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
4. FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
5. P. aeruginosa negative, based on one of the following criteria:

   1. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
   2. 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.

Exclusion criteria:

1. Age \< 8 years
2. Intermittently or chronically infected with Pa
3. Unable to expectorate sputum or undergo sputum induction
4. FEV1 \< 30%
5. History of lung transplant
6. 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.

Inclusion Criteria, Non-Expectorating Cohort (n=10):

1. Male or female, ages 3-8 years
2. 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:

1. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
2. 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.

Exclusion criteria:

1. Age \< 3 years
2. Intermittently or chronically infected with Pa
3. FEV1 \< 30%
4. History of lung transplant
5. 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.

Where this trial is running

Phoenix, Arizona and 6 other locations

• Phoenix Children's Hospital — Phoenix, Arizona, United States (Completed)
• Children's Hospital Colorado — Aurora, Colorado, United States (Completed)
• National Jewish Health — Denver, Colorado, United States (Completed)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Not_yet_recruiting)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Completed)
• BC Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
• St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Jane E Hill, PhD — University of British Columbia
• Study coordinator: Jane E Hill, PhD

Conditions Cystic Fibrosis; Breath; IMPACT