- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121117
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Agustín Valido Morales
- Phone Number: 955 00 80 00
- Email: agustins.valido.sspa@juntadeandalucia.es
Study Locations
-
-
-
Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 35 years old
- Accumulative tobacco rate > 10 paq-year that go to the tobacco detoxication consultation
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tobacco detoxication cohort
Patients appointed in a tobacco detoxication consultation
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months after the first consultation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Agustín Valido Morales, Hospital Universitario Virgen Macarena
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS-COP6-2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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