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

October 9, 2019 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Smoker patients that are treated in the tobacco detoxication consultation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Agustín Valido Morales, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2019

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

June 15, 2020

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

September 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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