CompletedNot Applicable

Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy

Switzerland35 participantsStarted 2020-11-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Exhaled Breath Metabolites

Timeframe: twice during 8 weeks

Trial details

NCT IDNCT04638920

SponsorMalcolm Kohler

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-30

Results submitted2025-01-29

View on ClinicalTrials.gov More COPD Exacerbation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.