NCT01380470

Brief Summary

The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region of Murcia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,052

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

December 15, 2017

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

June 22, 2011

Last Update Submit

December 14, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseDiagnosis differentialDyspnea/classificationDyspnea/etiology

Outcome Measures

Primary Outcomes (1)

  • FEV1/FVC,Forced Expiratory Volume 1/ Forced Vital Capacity

    15 days

Study Arms (1)

Chronic Obstructive Pulmonary Disease

Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years.

You may qualify if:

  • Aged between 40 and 70 years of both sexes
  • With a history of smoking (current or past)
  • Do not diagnosed with COPD at the time of completion of study

You may not qualify if:

  • Prior diagnosis of COPD or Asthma
  • A condition prevents performing spirometry
  • Patients displaced
  • For those diagnosed with COPD:
  • Subject treated in CS there is explicit evidence for the disease
  • Subjects who at the time of the consultation arouse suspicion of previously undiagnosed COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Murcia, Murcia, 30003, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Asensio Lopez Santiago, MD

    Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

December 15, 2017

Record last verified: 2011-06

Locations

ES(1)