Chronic Obstructive Pulmonary DiseaseNCT04121117
Usefulness of the Chronic Obstructive Pulmonary Disease-population (COPD-PS) Questionnaire and the COPD-6 Device in the Chronic Obstructive Pulmonary Disease Detection in a Tobacco Detoxication Consultation
An observational study of Chronic Obstructive Pulmonary Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (COPD-PS) and the COPD-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients . Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Chronic obstructive pulmonary disease screening
- How many people
- 245 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2019to 15 Jun 2020
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Smoker patients that are treated in the tobacco detoxication consultation
Who may be able to join
- > 35 years old
- Accumulative tobacco rate > 10 paq-year that go to the tobacco detoxication consultation
Who cannot join
- Unable to fulfill the questionnarie
- Unable to adequately perform the COPD-6 or forced spirometry maneuvers included in the study.
- Reject to participate and sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (COPD-PS) and the COPD-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients .
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Chronic obstructive pulmonary disease screening
- Keywords
- Chronic obstructive pulmonary disease, COPD, Chronic obstructive pulmonary disease population questionnaire, COPD-PS, COPD-6
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic obstructive pulmonary disease screeningOther
To verify the tobacco withdrawal, the patients will make a cooximetry.
For the detection of a possible obstructive pattern a measurement of the ventilatory capacity will be make using the COPD-6 device and for the confirmation of COPD diagnosis and the assesment of the airflow obstruction severity a spirometry will be make.
The patients will also complete the COPD-PS questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco detoxication cohort | Patients appointed in a tobacco detoxication consultation Receives: Other: Chronic obstructive pulmonary disease screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the usefulness in the COPD early detection of the combination of the COPD-PS questionnaire and the COPD-6 device.
Verify if the combination of the COPDS-questionnaire (made of different items that allow the detection of chronic airflow obstruction) and the COPD-6 device (tool that measures the ventilatory capacity) is suitable for the COPD early detection.
Measured: Up to 12 months after the first consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agustín Valido Morales, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121117
- Sponsor's protocol ID
- FIS-COP6-2018-01
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of the Chronic Obstructive Pulmonary Disease-population (COPD-PS) Questionnaire and the COPD-6 Device in the Chronic Obstructive Pulmonary Disease Detection in a Tobacco Detoxication Consultation
- ClinicalTrials.gov ID
- NCT04121117
- Acronym / sponsor ID
- FIS-COP6-2018-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD, Chronic obstructive pulmonary disease population questionnaire, COPD-PS, COPD-6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 9 Oct 2019 (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.
The aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (COPD-PS) and the COPD-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients .
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco detoxication cohort | – | Other: Chronic obstructive pulmonary disease screeningPatients appointed in a tobacco detoxication consultation |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Smoker patients that are treated in the tobacco detoxication consultation
Key inclusion criteria (2 listed)
- > 35 years old
- Accumulative tobacco rate > 10 paq-year that go to the tobacco detoxication consultation
Key exclusion criteria (3 listed)
- Unable to fulfill the questionnarie
- Unable to adequately perform the COPD-6 or forced spirometry maneuvers included in the study.
- Reject to participate and sign the informed consent.
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 |
|---|---|---|
| Chronic obstructive pulmonary disease screeningTo verify the tobacco withdrawal, the patients will make a cooximetry. For the detection of a possible obstructive pattern a measurement of the ventilatory capacity will be make using the COPD-6 device and for the confirmation of COPD diagnosis and the assesment of the airflow obstruction severity a spirometry will be make. The patients will also complete the COPD-PS questionnaire. | Other | Tobacco detoxication cohort |
Primary outcome
Evaluate the usefulness in the COPD early detection of the combination of the COPD-PS questionnaire and the COPD-6 device.
Time frame: Up to 12 months after the first consultation
Verify if the combination of the COPDS-questionnaire (made of different items that allow the detection of chronic airflow obstruction) and the COPD-6 device (tool that measures the ventilatory capacity) is suitable for the COPD early detection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
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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.
Agustín Valido Morales principal investigator
Hospital Universitario Virgen Macarena
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 Chronic Obstructive Pulmonary Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agustín Valido Morales (955 00 80 00, agustins.valido.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the usefulness in the COPD early detection of the combination of the COPD-PS questionnaire and the COPD-6 device. (time frame: Up to 12 months after the first consultation). 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 11 Oct 2019.