COPD ExacerbationBDSNCT05440188
Study to Identify the Reduction of Exacerbations Resulting in Hospital Admission in Patients With COPD.
An observational study of COPD Exacerbation, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Breath Detect Platform
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 23 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients from Primary Health Care, Elderly care homes, and HULP
Who may be able to join
- COPD diagnosed in GOLD II state or higher
Who cannot join
- Can´t read and talk in spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Reduction of Exacerbations Resulting in Hospital Admission in COPD Patients After the Use of the Breath Detect Telemedicine Platform.
identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform.
- Conditions
- COPD Exacerbation
- Being tested
- Breath Detect Platform
- Keywords
- telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Detect PlatformDiagnostic test
Use of the Breath Detect platform for respiratory health monitoring.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Patients over 65 years old diagnosed with COPD in GOLD II state or higher who uses Breath Detect Platform for monitoring their respiratory health status. Receives: Diagnostic Test: Breath Detect Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital admissions due to exacerbations
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Oct 2022
- Primary completion23 Aug 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440188
- Sponsor's protocol ID
- Breath Detect Study
- Acronym
- BDS
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Reduction of Exacerbations Resulting in Hospital Admission in COPD Patients After the Use of the Breath Detect Telemedicine Platform.
- ClinicalTrials.gov ID
- NCT05440188
- Acronym / sponsor ID
- BDS / Breath Detect Study
- Conditions
- COPD Exacerbation
- Keywords
- telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Diagnostic Test: Breath Detect PlatformPatients over 65 years old diagnosed with COPD in GOLD II state or higher who uses Breath Detect Platform for monitoring their respiratory health status. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients from Primary Health Care, Elderly care homes, and HULP
Key inclusion criteria (1 listed)
- COPD diagnosed in GOLD II state or higher
Key exclusion criteria (1 listed)
- Can´t read and talk in spanish
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 |
|---|---|---|
| Breath Detect PlatformUse of the Breath Detect platform for respiratory health monitoring. | Diagnostic test | COPD |
Primary outcome
Number of hospital admissions due to exacerbations
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 Universidad Autonoma de Madrid at 1 site in Spain.
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 1 inclusion and 1 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 6 Dec 2023. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of hospital admissions due to exacerbations (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2023.