COPD ExacerbationTripleEXNCT04638920
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
An observational study of COPD Exacerbation, run by Malcolm Kohler at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2020to 30 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation
Who may be able to join
- Informed consent
- age >= 18 years
- staged according to GOLD recommendations
- GOLD stage 2-4, GOLD ABE classification
- hospitalization due to COPD exacerbation
- subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
- suitable for follow-up assessment
- <48 hours after initiation of antibiotic therapy or systemic steroid therapy
Who cannot join
- physical or intellectual impairment precluding informed consent or protocol adherence
- known pregnancy
- congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
- uncontrolled diabetes (e.g. HbA1c >11% or Glc >20mmol/l)
- acute or chronic pulmonary disease other than COPD
- renal failure or renal replacement therapy (GFR < 15 mL/min)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)
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.
- Conditions
- COPD Exacerbation
- Being tested
- No intervention
- Keywords
- Exhaled breath analysis, Mass spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Exacerbators | Patients with acute COPD exacerbation under triple inhalation therapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: twice during 8 weeks
Secondary outcomes (4)
Symptoms
Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation
Measured: twice during 8 weeks
Inflammation
Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation
Measured: twice during 8 weeks
Causative Agents
Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation
Measured: twice during 8 weeks
Treatment
Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation
Measured: measured once during COPD exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Nov 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malcolm Kohler
- Sponsor type
- University, hospital or other
- Collaborators
- Deep Breath Intelligence (DBI)
- Responsible party
- Sponsor-investigator, Malcolm Kohler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638920
- Sponsor's protocol ID
- BASEC-Nr. 2020-01954
- Acronym
- TripleEX
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2020
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41013424
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)
- ClinicalTrials.gov ID
- NCT04638920
- Acronym / sponsor ID
- TripleEX / BASEC-Nr. 2020-01954
- Conditions
- COPD Exacerbation
- Keywords
- Exhaled breath analysis, Mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Malcolm KohlerUniversity, hospital or other
- Collaborators
- Deep Breath Intelligence (DBI)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exacerbators | – | Other: No interventionPatients with acute COPD exacerbation under triple inhalation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation
Key inclusion criteria (8 listed)
- Informed consent
- age >= 18 years
- staged according to GOLD recommendations
- GOLD stage 2-4, GOLD ABE classification
- hospitalization due to COPD exacerbation
Key exclusion criteria (6 listed)
- physical or intellectual impairment precluding informed consent or protocol adherence
- known pregnancy
- congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
- uncontrolled diabetes (e.g. HbA1c >11% or Glc >20mmol/l)
- acute or chronic pulmonary disease other than COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Exacerbators |
Primary outcome
Change in Exhaled Breath Metabolites
Time frame: twice during 8 weeks
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.
4 secondary outcomes
Symptoms
Time frame: twice during 8 weeks
Inflammation
Time frame: twice during 8 weeks
Causative Agents
Time frame: twice during 8 weeks
Treatment
Time frame: measured once during COPD exacerbation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41013424Sievi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Malcolm Kohler at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exhaled Breath Metabolites (time frame: twice during 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.