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

NCT04121117 | Unknown

• 1 other identifier: FIS-COP6-2018-01
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; COPD; Chronic obstructive pulmonary disease population questionnaire; COPD-PS; COPD-6

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tobacco detoxication cohort

Patients appointed in a tobacco detoxication consultation

Other: Chronic obstructive pulmonary disease screening

Interventions

Chronic obstructive pulmonary disease screening OTHER

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.

Tobacco detoxication cohort

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Smoker patients that are treated in the tobacco detoxication consultation

You may qualify if:

• \> 35 years old
• Accumulative tobacco rate \> 10 paq-year that go to the tobacco detoxication consultation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Agustín Valido Morales

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agustín Valido Morales

CONTACT

955 00 80 00; agustins.valido.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 9, 2019
• Study Start: October 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: June 15, 2020
• Last Updated: October 11, 2019

Record last verified: 2019-09

Locations

ES (1)