CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 544 enrolled
Drug / intervention
An exhaled breath testother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05293314
NCT05293314N/ACompleted

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

Shanghai Pulmonary Hospital, Shanghai, China·observational·Posted Mar 24, 2022·Updated Nov 19, 2024

In Brief

An observational study evaluating An exhaled breath test for Bronchiectasis. Completed, enrolled 544 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiectasis
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 24, 2022
Enrollment StartJul 1, 2022
Primary CompletionMay 1, 2023
Study CompletionMay 20, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.3 years ago

Interventions

An exhaled breath testother

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.