Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121117
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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 .

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Chronic obstructive pulmonary disease screening

Layout table for study information
Study Type : Observational
Estimated Enrollment : 245 participants
Observational Model: Case-Only
Time Perspective: Other
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
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Smoker patients that are treated in the tobacco detoxication consultation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121117


Contacts
Layout table for location contacts
Contact: Agustín Valido Morales 955 00 80 00 agustins.valido.sspa@juntadeandalucia.es

Locations
Layout table for location information
Spain
Hospital Universitario Virgen Macarena Completed
Sevilla, Spain, 41009
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
Principal Investigator: Agustín Valido Morales Hospital Universitario Virgen Macarena

Layout table for additonal information
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04121117     History of Changes
Other Study ID Numbers: FIS-COP6-2018-01
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Chronic obstructive pulmonary disease
COPD
Chronic obstructive pulmonary disease population questionnaire
COPD-PS
COPD-6
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases