Non-interventional, Cross-sectional, Multicenter Study to Describe the Exacerbations Profile of COPD Patients Treated With ICS in a Real-life Primary Care Population in Spain. OPTI Study.

Boehringer Ingelheim168 sites in 1 country901 target enrollmentAugust 14, 2018

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsInhaled corticosteroid

DrugsInhaled corticosteroid

Overview

Phase: N/A
Intervention: Inhaled corticosteroid
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 901
Locations: 168
Primary Endpoint: Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.

Registry

clinicaltrials.gov

Start Date

August 14, 2018

End Date

January 31, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent prior to participation
•Female and male patient ≥ 40 years of age
•Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
•Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio \<70%)
•Clinical data available 2 years before the study visit
•Ability to complete CAT - COPD Assessment Test

Exclusion Criteria

•Current participation in any clinical trial involving a drug or device
•A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit

Arms & Interventions

subjects with Pulmonary Disease, Chronic Obstructive

Intervention: Inhaled corticosteroid

Outcomes

Primary Outcomes

Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit

Time Frame: 1 year prior to study visit, data collected at study visit (1 day).

Percentage of patients currently on ICS who did not have moderate or severe exacerbation in the year prior to the study visit, (i.e. within the last 365 days before the study visit). Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.

Secondary Outcomes

Number of Moderate or Severe Exacerbations in Patients Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit.)
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit(1 year prior to study visit, data collected at study visit (1 day).)
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017(1 year prior to study visit, data collected at study visit (1 day).)
Percentage of Patients With ICS-related Adverse Events(2 years prior to study visit, data collected at study visit (1 day).)
Percentage of Patients Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, in the Previous 2 Years Before the Study Visit(2 years prior to study visit, data collected at study visit (1 day).)
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit (1 day).)
Number of Moderate or Severe Exacerbations in Patients Not Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit.)
Percentage of Patients Using Rescue Medication(1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).)
General Patient Profile - Body Mass Index (BMI)(2 years prior to study visit, data collected at study visit (1 day).)
General Patient Profile - Number of Patients by Smoking Habit(2 years prior to study visit, data collected at study visit (1 day).)
General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis(Data collected at study visit.)
General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index(2 years prior to study visit, auto-calculated at study visit (1 day).)
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification(2 years prior to study visit, auto-calculated at study visit.)
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups(2 years prior to study visit, auto-calculated at study visit.)
General Patient Profile - COPD Assessment Test (CAT) Score(Data measured at study visit.)
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment(2 years prior to study visit, data collected at study visit.)
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score(Data measured at study visit.)
General Patient Profile - Number of Patients by Level of Eosinophils(2 years prior to study visit, data collected at study visit (1 day).)