N/A N=544

Assessment of an Exhaled Breath Test to Detect Bronchiectasis

Bronchiectasis

Bottom Line

View on ClinicalTrials.gov: NCT05293314 ↗

Enrolled (actual)

544

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People — 65; 67; 23 Participants — p=<0.05

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: An exhaled breath test (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People	65; 67; 23	<0.05 sig
SECONDARY The Sensitivity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People	65; 67; 23	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05293314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.