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To investigate whether the breath test is able to detect bronchiectasis using breathomics. This study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate the accuracy of breathomics to diagnosis of bronchiectasis in adults.
Bronchiectasis is a chronic airway inflammation with irreversible expansion of bronchial walls, which is characteristic by chronic cough, mucinous sputum, dyspnea and wheezing. High resolution CT (HRCT) combined with clinical manifestations is the main diagnostic method of bronchiectasis, but HRCT is expensive and radioactive. Therefore, it is urgent to develop a new technology to diagnose bronchiectasis. Exhaled breath may be a better tool for bronchiectasis detection because of its noninvasive nature. Many efforts have been made to develop breath tests for lung cancer, asthma and Helicobacter pylori infection. However, little studies pay attention to bronchiectasis. High-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS) is a promising tool for breath testing, because it is highly sensitive, does not require pretreatment of exhaled breath, and holds great tolerance for humidity. In our case-control diagnostic study, we investigated whether a breath test combining HPPI-TOFMS and a support vector machine (SVM) algorithm was able to distinguish patients with bronchiectasis from control individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with bronchiectasis (BE) | Diagnosis of bronchiectasis was performed using chest HRCT scans in suspected patients with coughing and expectoration, or long durations of haemoptysis. High-resolution images were obtained during full inspiration at 1-mm collimation and 10-mm intervals from the apex to the base of the lungs. The presence of bronchiectasis was confirmed based on the following criteria: 1) lack of tapering in the bronchi; 2) dilation of the bronchi where the internal diameter was larger than that of the adjacent pulmonary artery; or 3) visualisation of the peripheral bronchi within 1 cm of the costal pleural surface or the adjacent mediastinal pleural surface. |
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| Healthy control group (HC) | Control group is healthy participants. |
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| Unhealthy control group (UHC) | Patients with interstitial lung disease or patients with Sarcoidosis. Interstitial lung disease is a heterogeneous pulmonary disease characterized with lung fibrosis and manifest with breathlessness. Sarcoidosis is a systemic disease of unknown etiology characterized by the formation of granulomas in various organs, mostly involved is the lungs and intrathoracic lymph nodes . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An exhaled breath test | Diagnostic Test | All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. Breath sample detection was based on the HPPI-TOFMS platform. |
| Measure | Description | Time Frame |
|---|---|---|
| The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model. | One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
| Measure | Description | Time Frame |
|---|---|---|
| The Sensitivity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Sensitivity=number of true positives/(number of true positives+number of false negatives) * 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model. |
| Measure | Description | Time Frame |
|---|---|---|
| The Specificity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) * 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model. |
Inclusion Criteria:
BE Patients were recruited according to the following inclusion criteria: (1) Age>18 years; (2) the diagnosis of BE was according to European Respiratory Society guidelines for the management of adult bronchiectasis; (3) Willing to join in and sign the informed consent form.
Healthy control subjects were recruited according to the following inclusion criteria:(1) Age>18 years; (2) No history of any lung disease (according to pulmonary imaging and physical examinations); (3) Willing to join in and sign the informed consent form.
Unhealthy control subjects were recruited according to the following inclusion criteria: (1) Age>18 years; (2) The diagnosis of ILD was according to HRCT and clinical symptoms by two experts' consensus; (3) The diagnosis of Sarcoidosis (SA) was according to American Thoracic Society Clinical Practice Guideline;(4) Willing to join in and sign the informed consent form.
Exclusion Criteria:
(1) Patients combined with serious comorbidities (chronic renal failure, hepatic disease, etc.); (2) Patients who are diagnosed with asthma, pneumonia, malignant tumor, and COPD; (3) Women who are pregnant or preparing for pregnancy or breastfeeding; (4) Participated in other clinical trials within three months; (5) Refused to join in and sign the informed consent form.
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The age of all subjects were all older than 18 . The study population was recruited from Shanghai pulmonary hospital. Diagnosis of bronchiectasis was performed using chest HRCT scans in suspected patients with coughing and expectoration, or long durations of haemoptysis. Idiopathic bronchiectasis patients with acute exacerbation were included in the study. Healthy participants (HC) and unhealthy participants(UHC) were as control.
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| Name | Affiliation | Role |
|---|---|---|
| Jin-fu Xu, MD | Department of Respiratory and Critical Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai pulmonary hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Bronchiectasis | Diagnosis of bronchiectasis was performed using chest HRCT scans in suspected patients with coughing and expectoration, or long durations of haemoptysis. High-resolution images were obtained during full inspiration at 1-mm collimation and 10-mm intervals from the apex to the base of the lungs. The presence of bronchiectasis was confirmed based on the following criteria: 1) lack of tapering in the bronchi; 2) dilation of the bronchi where the internal diameter was larger than that of the adjacent pulmonary artery; or 3) visualisation of the peripheral bronchi within 1 cm of the costal pleural surface or the adjacent mediastinal pleural surface. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| FG001 | Healthy Control Group | Control group is healthy participants. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| FG002 | Unhealthy Control Group | Patients with interstitial lung disease or patients with Sarcoidosis. Interstitial lung disease is a heterogeneous pulmonary disease characterized with lung fibrosis and manifest with breathlessness. Sarcoidosis is a systemic disease of unknown etiology characterized by the formation of granulomas in various organs, mostly involved is the lungs and intrathoracic lymph nodes . an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Bronchiectasis | Diagnosis of bronchiectasis was performed using chest HRCT scans in suspected patients with coughing and expectoration, or long durations of haemoptysis. High-resolution images were obtained during full inspiration at 1-mm collimation and 10-mm intervals from the apex to the base of the lungs. The presence of bronchiectasis was confirmed based on the following criteria: 1) lack of tapering in the bronchi; 2) dilation of the bronchi where the internal diameter was larger than that of the adjacent pulmonary artery; or 3) visualisation of the peripheral bronchi within 1 cm of the costal pleural surface or the adjacent mediastinal pleural surface. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model. | All participants were randomly divided to a discovery cohort (n=252), an internal validation cohort (n=103) and a blinded test cohort (n=155). The main outcomes were assumed by the data analysed from the blinded test cohort which was mentioned above. | Posted | Count of Participants | Participants | One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
|
1 day
If a participant experiences a progressive decrease in blood pressure or cardiac arrest within one day after being collected breath sample, we define a serious adverse event as occurring.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Bronchiectasis | Diagnosis of bronchiectasis was performed using chest HRCT scans in suspected patients with coughing and expectoration, or long durations of haemoptysis. High-resolution images were obtained during full inspiration at 1-mm collimation and 10-mm intervals from the apex to the base of the lungs. The presence of bronchiectasis was confirmed based on the following criteria: 1) lack of tapering in the bronchi; 2) dilation of the bronchi where the internal diameter was larger than that of the adjacent pulmonary artery; or 3) visualisation of the peripheral bronchi within 1 cm of the costal pleural surface or the adjacent mediastinal pleural surface. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Only 2 of bronchiectasis participants and 1 of unhealthy controls cough transiently. However, they all returned to normal after taking a 10 minute break. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin-Fu Xu | Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, School of Medicine, Tongji University，Shanghai, China | 008621 65115006 | jfxu@tongji.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2023 | Sep 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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organic components in exhaled breath
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| One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
| One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
| BG001 | Healthy Control Group | Control group is healthy participants. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| BG002 | Unhealthy Control Group | Patients with interstitial lung disease or patients with Sarcoidosis. Interstitial lung disease is a heterogeneous pulmonary disease characterized with lung fibrosis and manifest with breathlessness. Sarcoidosis is a systemic disease of unknown etiology characterized by the formation of granulomas in various organs, mostly involved is the lungs and intrathoracic lymph nodes . an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI(Body Mass Index) | Median | Inter-Quartile Range | kg/m^2 |
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| Smoking | Count of Participants | Participants |
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| Alcohol | Count of Participants | Participants |
|
(1) Age>18 years, the diagnosis of bronchiectasis need reference to the definition of "idiopathic bronchiectasis" according to British Thoracic Society in 2010 or 2012 China bronchiectasis expert consensus; (2) Patients are clinically diagnosed as acute attack (AE) and need hospitalization, that is, they have the following three or more clinical symptoms within 48 hours: Cough; Changes in the amount or character of sputum; Purulent sputum; Shortness of breath or decreased exercise tolerance; weakness hemoptysis; (3) Patient quit smoking for more than two years; (4) Willing to join in and sign the informed consent form.
| OG001 | Healthy Controls | (1) Age>18 years; (2) No history of any lung disease (except for the history of pneumonia in the past time and small pulmonary nodules); (3) Willing to join in and sign the informed consent form. |
| OG002 | Unhealthy Controls | Participants with interstitial lung disease or patients with Sarcoidosis. |
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| Secondary | The Sensitivity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Sensitivity=number of true positives/(number of true positives+number of false negatives) * 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model. | All participants were randomly divided to a discovery cohort (n=252), an internal validation cohort (n=103) and a blinded test cohort (n=155). The main outcomes were assumed by the data analysed from the blinded test cohort which was mentioned above. | Posted | Count of Participants | Participants | One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
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|
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| Other Pre-specified | The Specificity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People | Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) * 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model. | All participants were randomly divided to a discovery cohort (n=252), an internal validation cohort (n=103) and a blinded test cohort (n=155). The main outcomes were assumed by the data analysed from the blinded test cohort which was mentioned above. | Posted | Count of Participants | Participants | One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week. |
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|
| 0 |
| 215 |
| 0 |
| 215 |
| 5 |
| 215 |
| EG001 | Healthy Control Group | Control group is healthy participants. an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. | 0 | 221 | 0 | 221 | 0 | 221 |
| EG002 | Unhealthy Control Group | Patients with interstitial lung disease or patients with Sarcoidosis. Interstitial lung disease is a heterogeneous pulmonary disease characterized with lung fibrosis and manifest with breathlessness. Sarcoidosis is a systemic disease of unknown etiology characterized by the formation of granulomas in various organs, mostly involved is the lungs and intrathoracic lymph nodes . an exhaled breath test: All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. | 0 | 74 | 0 | 74 | 2 | 74 |
|
| short of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Only 3 of bronchiectasis participants and 1 of unhealthy controls feel short of breath transiently. However, they all returned to normal after taking a 10 minute break. |
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| Male |
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| Non-smoker |
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| No record |
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| Non-drinker |
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| No record |
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| Sensitivity=number of true positives/(number of true positives+number of false negatives) * 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model. | Sensitivity | 86.2 | 2-Sided | 95 | 77.1 | 95.2 | Other | Sensitivity=number of true positives/(number of true positives+number of false negatives) * 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model. |
| Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) * 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model. | Specificity | 73.9 | 2-Sided | 95 | 56 | 91.9 | Other | Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) * 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model. |