Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Deep Breath Intelligence (DBI) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exacerbators | Patients with acute COPD exacerbation under triple inhalation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exhaled Breath Metabolites | Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature. | twice during 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation | twice during 8 weeks |
| Inflammation | Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41013424 | Derived | Sievi NA, Schmidt F, Fricke K, Baur DM, Basler S, Herth J, Kohler M. Acute COPD exacerbation despite triple inhaled therapy: a molecular insight - TripleEx study. Respir Res. 2025 Sep 26;26(1):273. doi: 10.1186/s12931-025-03352-0. |
Not provided
Not provided
Not provided
Patients were recruited at the University Hospital Zurich between November 2020 and April 2024. Study duration was extended due to lack of sufficient patients until July 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exacerbators | Patients with acute exacerbation of COPD under triple exhalation therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data of 28 participants were included in the final analysis as five patients withdrew their participation and the main outcome (breath analysis) of two participants was not analyzable.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exacerbators | Patients with acute exacerbation of COPD under triple exhalation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Exhaled Breath Metabolites | Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature. | Exhaled breath data of two participants were not analazable due to technical problems. | Posted | Number | breath metabolites | twice during 8 weeks |
|
Serious events were collected during study period between time of inclusion (acute COPD exacerbation) and follow-up visit at stable state approximately 8 weeks after inclusion.
Serious event were defined as follows:
Any unfavorable event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exacerbators | Patients with acute COPD exacerbation under triple inhalation therapy No intervention: No intervention |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Malcolm Kohler, Sponsor-Investigator | University Hospital Zurich | +41442551111 | malcolm.kohler@usz.ch |
Not provided
| 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 | Sep 2, 2020 | Jan 29, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| twice during 8 weeks |
| Causative Agents | Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation | twice during 8 weeks |
| Treatment | Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation | measured once during COPD exacerbation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| GOLD ABE classification | The classification incorporates patients' symptomatic assessemetn and risk of exacerbation. Class A shows less symptoms and 0 to 1 moderate exacerbation in the previous year. Class B shows high symptoms and 0 to 1 moderate exacerbation in the previous year. Class E shows high symptoms and ≥ 2 moderate exacerbations or ≥ 1 leading to hospitalization. | Count of Participants | Participants | No |
|
| Exacerbation history | acute COPD exacerbation history in the previous year | Mean | Standard Deviation | events |
|
| Treatment during acute COPD exacerbation | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Symptoms | Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation | Not Posted | twice during 8 weeks | Participants |
| Secondary | Inflammation | Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation | Not Posted | twice during 8 weeks | Participants |
| Secondary | Causative Agents | Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation | Not Posted | twice during 8 weeks | Participants |
| Secondary | Treatment | Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation | Not Posted | measured once during COPD exacerbation | Participants |
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
Not provided
Not provided