Trial Outcomes & Findings for Assessment of an Exhaled Breath Test to Detect Bronchiectasis (NCT NCT05293314)
NCT ID: NCT05293314
Last Updated: 2024-11-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
544 participants
Primary outcome timeframe
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.
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
228
|
231
|
85
|
|
Overall Study
COMPLETED
|
215
|
221
|
74
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Bronchiectasis
n=215 Participants
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.
|
Healthy Control Group
n=221 Participants
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.
|
Unhealthy Control Group
n=74 Participants
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.
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=215 Participants
|
52 years
n=221 Participants
|
65 years
n=74 Participants
|
56 years
n=510 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=215 Participants
|
145 Participants
n=221 Participants
|
33 Participants
n=74 Participants
|
328 Participants
n=510 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=215 Participants
|
76 Participants
n=221 Participants
|
41 Participants
n=74 Participants
|
182 Participants
n=510 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI(Body Mass Index)
|
21.1 kg/m^2
n=215 Participants
|
23.9 kg/m^2
n=221 Participants
|
24.2 kg/m^2
n=74 Participants
|
22.9 kg/m^2
n=510 Participants
|
|
Smoking
Smoker
|
27 Participants
n=215 Participants
|
40 Participants
n=221 Participants
|
28 Participants
n=74 Participants
|
95 Participants
n=510 Participants
|
|
Smoking
Non-smoker
|
183 Participants
n=215 Participants
|
162 Participants
n=221 Participants
|
46 Participants
n=74 Participants
|
391 Participants
n=510 Participants
|
|
Smoking
No record
|
5 Participants
n=215 Participants
|
19 Participants
n=221 Participants
|
0 Participants
n=74 Participants
|
24 Participants
n=510 Participants
|
|
Alcohol
Drinker
|
6 Participants
n=215 Participants
|
11 Participants
n=221 Participants
|
3 Participants
n=74 Participants
|
20 Participants
n=510 Participants
|
|
Alcohol
Non-drinker
|
204 Participants
n=215 Participants
|
173 Participants
n=221 Participants
|
71 Participants
n=74 Participants
|
448 Participants
n=510 Participants
|
|
Alcohol
No record
|
5 Participants
n=215 Participants
|
37 Participants
n=221 Participants
|
0 Participants
n=74 Participants
|
42 Participants
n=510 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Bronchiectasis Participants
n=215 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.
|
Healthy Controls
n=221 Participants
(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.
|
Unhealthy Controls
n=74 Participants
Participants with interstitial lung disease or patients with Sarcoidosis.
|
|---|---|---|---|
|
The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People
|
65 Participants
|
67 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Bronchiectasis Participants
n=215 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.
|
Healthy Controls
n=221 Participants
(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.
|
Unhealthy Controls
n=74 Participants
Participants with interstitial lung disease or patients with Sarcoidosis.
|
|---|---|---|---|
|
The Sensitivity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People
|
65 Participants
|
67 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Bronchiectasis Participants
n=215 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.
|
Healthy Controls
n=221 Participants
(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.
|
Unhealthy Controls
n=74 Participants
Participants with interstitial lung disease or patients with Sarcoidosis.
|
|---|---|---|---|
|
The Specificity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People
|
65 Participants
|
67 Participants
|
23 Participants
|
Adverse Events
Patients With Bronchiectasis
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unhealthy Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Bronchiectasis
n=215 participants at risk
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.
|
Healthy Control Group
n=221 participants at risk
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.
|
Unhealthy Control Group
n=74 participants at risk
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
2/215 • 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.
|
0.00%
0/221 • 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.
|
1.4%
1/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
1.4%
3/215 • 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.
|
0.00%
0/221 • 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.
|
1.4%
1/74 • 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.
|
Additional Information
Jin-Fu Xu
Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, School of Medicine, Tongji University，Shanghai, China
Phone: 008621 65115006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place