The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.

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

Official Title
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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.

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Inhaled corticosteroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects with Pulmonary Disease, Chronic Obstructive<br> | Drug: Inhaled corticosteroid<br>* Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit | 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. | 1 year prior to study visit, data collected at study visit (1 day). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit | Percentage of patients currently on ICS who have had 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. | 1 year 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 | Percentage of patients with chronic obstructive pulmonary disease (COPD) 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. 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. | 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 | Percentage of patients with chronic obstructive pulmonary disease (COPD) treated with Inhaled CorticoSteroids (ICS) at the time of study visit with or without moderate or serve exacerbations, both in the previous 1 year and previous 2 years 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. | 1 year and 2 years prior to study visit, data collected at study visit (1 day). | 
| 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 | Number of moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) patients treated with ICS at the time of study visit, both in previous 1 year and previous 2 years 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. | 1 year and 2 years prior to study visit, data collected at study visit. | 
| 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 | Number of moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) patients not treated with ICS at the time of study visit, both in previous 1 year and previous 2 years 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. | 1 year and 2 years prior to study visit, data collected at study visit. | 
| Percentage of Patients Using Rescue Medication | Percentage of patients who used rescue medication (by type of rescue medication) in the last year and in the last two years. This percentage was calculated using as denominator the FAS set and was stratified by ICS treatment in the study visit. Data was obtained from medical charts. SABA: Short-acting beta2- agonists [*]: Salbutamol alone, terbutaline alone and salbutamol in combination (IPRATROPIUM BROMIDE /SALBUTAMOL) are included. | 1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day). | 
| Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017 | Number of patients with adherence to treatment recommendations according GesEPOC 2017 guidelines, stratified by risk and phenotypes. Adherence: Patients treated with Inhaled CorticoSteroids (ICS) that according to GesEPOC 2017 should had been treated with ICS; Patients not treated with ICS that according to GesEPOC 2017 should not had been treated with ICS. Non-adherence: Patients treated with ICS but according to GesEPOC 2017 should not have been treated with ICS; Patients not treated with ICS but according to GesEPOC 2017 should have been treated with ICS. Low risk: Patients with Forced Expiratory Volume in 1st second (FEV1) post bronchodilator ≥50% and Modified Medical Research Council (mMRC) (0-1-2) and with ≤1 moderate/severe exacerbation without hospitalization in the last year. High risk: Patients with FEV1 post bronchodilator <50% or mMRC (3-4) and ≥2 moderate/severe exacerbation or severe ≥1 in the last year. Current phenotype was assigned to high risk patients. | 1 year prior to study visit, data collected at study visit (1 day). | 
| Percentage of Patients With ICS-related Adverse Events | Percentage of patients with adverse reactions commonly related to Inhaled CorticoSteroids (ICS), which were predefined in the eCRF and per protocol. In this sense, it could be the case of a patient reporting a commonly ICS-related adverse event, without current treatment with ICS at the time of the study visit. Data were obtained from medical charts. Results were reported for COPD patients overall (both arms combined), as the outcome is not related with the current ICS treatment of a patient. | 2 years prior to study visit, data collected at study visit (1 day). | 
| General Patient Profile - Body Mass Index (BMI) | General patient profile for patients treated with inhaled corticosteroid (ICS) and patients not treated with ICS - Body Mass Index (BMI). Weight (in kg) and height (in cm) were collected in the electronic case report form (eCRF). Body Mass Index was calculated (with last measure available): BMI (kg/m^2) = weight (kg)/ height (m). BMI is categorized into 5 categories according to the World Health Organization (WHO): Underweight: BMI< 18.5 kg/m^2; Normal weight: 18.5 kg/m^2 ≤ BMI ≤ 25 kg/m^2; Overweight: 25 kg/m^2< BMI ≤ 30 kg/m^2; Obese: 30 kg/m^2 < BMI ≤ 35 kg/m^2; Severely Obese: BMI > 35 kg/m^2. | 2 years prior to study visit, data collected at study visit (1 day). | 
| General Patient Profile - Number of Patients by Smoking Habit | General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS. Number of patients by smoking habit (non-smoker, smoker, ex-smoker). | 2 years prior to study visit, data collected at study visit (1 day). | 
| General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis | General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - time since COPD diagnosis. The year of the COPD diagnosis was collected in the electronic case report form (eCRF). The number of years since diagnosis was obtained as the difference between year of study visit and year of COPD diagnosis (+1). | Data collected at study visit. | 
| General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification | General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - Number of patients by GOLD 2019 spirometric classification. GOLD 2019 spirometric classification was auto-calculated according to the information recorded in the eCRF. While the protocol of the study planned to use GOLD 2017 guidelines, guideline updates were expected and it was planned to consider these updates for analysis purposes. For this reason, given that the GOLD 2019 guidelines were updated and effective, this guideline was used for auto-calculation. Spirometric data was collected from clinical records. To determine the severity of all subjects with COPD, patients were categorized into four levels based on their airflow limitation severity (based on post-bronchodilator FEV1 value): Gold 1 (mild): FEV1 (%) ≥ 80% predicted; Gold 2 (Moderate): 50% ≤ FEV1 (%) < 80% predicted; Gold 3 (Severe): 30% ≤ FEV1 (%) < 50% predicted; Gold 4 (Very serious): FEV1 (%) < 30% predicted. | 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 | General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - Number of patients by GOLD 2019 patient group (group A, group B, group C, group D). The GOLD 2019 patient group was auto-calculated according the information recorded in the eCRF. According to GOLD 2019 classification, four different types of patient groups were considered regarding their symptom burden and risk of exacerbation (exacerbations, Modified Medical Research Council (mMRC) and COPD Assessment Test (CAT) scores obtained from the eCRF): Group A: 0 or 1 exacerbations (not leading to hospital admission) and mMRC 0-1 and CAT < 10; Group B: 0 or 1 exacerbations (not leading to hospital admission), and mMRC ≥ 2 or CAT ≥ 10; Group C: ≥ 2 exacerbations or ≥ 1 exacerbation leading to hospital admission, and mMRC 0-1 and CAT < 10; Group D: ≥2 exacerbations or any ≥ 1 exacerbation leading to hospital admission, and mMRC ≥ 2 or CAT ≥ 10. | 2 years prior to study visit, auto-calculated at study visit. | 
| General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index | General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - BODEx index. The BODEx index is used to predict the mortality rate from chronic obstructive pulmonary disease (COPD). The BODEx index was auto-calculated according the information recorded in the eCRF. It includes the body mass index (BMI), the degree of dyspnea measured with the mMRC (Modified Medical Research Council) scale, the pulmonary function measured with the FEV1 (%) post-bronchodilation and the number of severe exacerbations (only visits to hospital emergencies and admissions are included). For each item, a score (0-3) is calculated. BODEx index is obtained as the sum of the scores of all items. The index ranges from 0 to 9, with a higher index indicating a higher risk of death. | 2 years prior to study visit, auto-calculated at study visit (1 day). | 
| General Patient Profile - COPD Assessment Test (CAT) Score | General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - CAT score. The CAT score was obtained from the sum of 8 items (cough, mucus, chest pressure, dyspnea, limitation in domestic activities, social limitation, sleep, energy). Each item ranging from 0 (no symptoms) to 5 points (highest symptoms). To obtain a valid score, no missing values or missing answers were allowed. The total score was obtained as the sum of the scores of all items, ranging from 0 - 40. The score was grouped into two categories: CAT <10: Low impact of COPD (Most days are good, the illness prevents the patient from doing one or two things he or she would like, coughing several days a week);CAT ≥10: Medium / high impact of COPD in the patient. | Data measured at study visit. | 
| General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score | General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - mMRC score. The mMRC score was used to assess severity of breathlessness in chronic obstructive pulmonary disease (COPD) patients. Patients were asked to answer the breathlessness scale (Mmrc), a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (grade 0) to almost complete incapacity (grade 4). A lower (higher) grade is considered a better (worse) outcome. Grade 0: None severity Grade 1: Mild severity Grade 2: Moderate severity Grade 3: Severe severity Grade 4: Very severe severity | Data measured at study visit. | 
| General Patient Profile - Number of Patients by Level of Eosinophils | General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - level of eosinophils. Reported is the number of patients by category (low number of eosinophils, high number of eosinophils). Data is obtained from medical charts. Eosinophils were collected in cells per microliter (µl) and the categories are defined as followed: Low number of eosinophils: < 300 cel/µl; High number of eosinophils: ≥ 300 cel/µl. | 2 years prior to study visit, data collected at study visit (1 day). | 
| General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment | General patient profile for patients treated with inhaled corticosteroid (ICS) and patients not treated with ICS: Current COPD treatment (treatment patterns for COPD) according to current treatment on ICS. Reported is the number of patients by current COPD treatment. Data is obtained from medical charts. LABA: Long-Acting Beta2-Agonist; LAMA: Long-Acting Muscarinic Antagonist; SABA: Short-acting beta2- agonists; SAMA: Short-acting muscarinic antagonist. | 2 years prior to study visit, data collected at study visit. |