Assessment of an Exhaled Breath Test to Detect Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Assessment of an Exhaled Breath Test Using High-Pressure Photon Ionization Time-of-Flight Mass Spectrometry to Detect Bronchiectasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293314
• Other study ID #: 20220303
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-fu Xu, MD
• Phone: +86 13321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 healthy individuals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 30, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Patients were recruited according to the following inclusion criteria: (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.

Control subjects were recruited according to the following inclusion criteria:(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.

Exclusion Criteria:

Patients were excluded according to the following criteria: (1) Bronchiectasis is caused by known causes: previous respiratory tract infections (especially measles and pertussis in dead infants and children, immune function defects (such as hypoimmunoglobulinemia, chronic granulomatous diseases, complement defects, HIV, etc.), genetic factors (such as ciliary dyskinesia, cystic pulmonary fibrosis, cartilage defects, etc.), airway obstruction and repeated aspiration; (2) Patients with a history of other respiratory diseases (cystic fibrosis, allergic bronchopulmonary aspergillosis, asthma, 1-antitrypsin deficiency, pulmonary tuberculosis, COPD, lung cancer, interstitial lung disease)and atopic diseases were excluded; (3) Serious comorbidities (chronic renal failure, hepatic disease, etc.) ; (4) Patients who are currently smoking or have quit smoking for less than 2 years; (5) Women who are pregnant or preparing for pregnancy or breastfeeding; (6) Participated in other clinical trials within three months.

Control subjects were excluded according to the following criteria: (1) Previous history of malignant tumor; (2) presence of active infections (such as tuberculosis, non-tuberculous mycobacterium disease) or liver disease; (3) women who are pregnant or preparing for pregnancy and are breastfeeding; (4) Current smoking, or smoking cessation less than 2 years.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Shanghai pulmonary hospital	Shanghai	Shanghai
China	Shanghai pulmonary hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of breathomics to distinguish bronchiectasis from healthy people	The accuracy of breathomics to distinguish bronchiectasis from healthy people was measured by the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve.	one year
Secondary	Assessment of the bronchiectasis severity according to breathomics	The severity of bronchiectasis was based on the BSI score and E-FACED score. Multivariable Logistic Regression Analyses would be used for the relationship between breathomics and the severity of bronchiectasis.	30 days