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NCT04121117 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04121117
Other study ID # FIS-COP6-2018-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 15, 2019
Est. completion date June 15, 2020

Study information
Verified date September 2019
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Agustín Valido Morales
Phone 955 00 80 00
Email agustins.valido.sspa@juntadeandalucia.es
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 245
Est. completion date June 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Chronic obstructive pulmonary disease screening
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.

Locations
Country Name City State
Spain Hospital Universitario Virgen Macarena Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 12 months after the first consultation
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