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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611777
• Other study ID #: 1237-0070
• Status: Completed
• Start date: August 14, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent prior to participation

2. Female and male patient = 40 years of age

3. Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit

4. Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio <70%)

5. Clinical data available 2 years before the study visit

6. Ability to complete CAT - COPD Assessment Test

Exclusion Criteria:

1. Current participation in any clinical trial involving a drug or device

2. A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inhaled corticosteroid
Drug

Locations

Country	Name	City	State
Spain	CS A Pontenova	A Pontenova, Lugo
Spain	CAP Abrera	Abrera, Barcelona
Spain	CS Zona IV	Albacete
Spain	CS Zona VI	Albacete
Spain	CS Nuestra Señora de la Oliva	Alcalá De Guadaira, Sevilla
Spain	EAP Carmen Calzado	Alcalá De Henares, Madrid
Spain	CS Alcasser	Alcasser, Valencia
Spain	CS La Chopera	Alcobendas, Madrid
Spain	CS Algeciras Norte	Algeciras, Cádiz
Spain	CS Algemesi	Algemesi, Valencia
Spain	CS Almonte	Almonte, Huelva
Spain	Consultorio Alpuente	Alpuente, Valencia
Spain	CS Argamasilla de Calatrava	Argamasilla De Calatrava, Ciudad Real
Spain	CS Baltar Sanxenxo	Baltar, Pontevedra
Spain	Consultorio Bañaderos	Bañaderos, Las Palmas
Spain	CAP Casanova	Barcelona
Spain	CAP Casernes	Barcelona
Spain	CAP Chafarinas	Barcelona
Spain	CAP Dr. Carles Ribas	Barcelona
Spain	CAP Sant Marti (EAP Verneda Nord)	Barcelona
Spain	Cap Sant Rafael	Barcelona
Spain	CAP Sants	Barcelona
Spain	CAP Trinitat Vella	Barcelona
Spain	EAP Guinardo	Barcelona
Spain	EAP Vía Roma	Barcelona
Spain	CS Bedman	Bedman, Jaén
Spain	Consultorio Médico Begíjar	Begíjar, Jaén
Spain	CS Benigánim	Benigánim, Valencia
Spain	C. S. Benimamet	Benimamet, Valencia
Spain	CS Santutxu	Bilbao
Spain	CS Comuneros	Burgos
Spain	CS Gamonal Antigua	Burgos
Spain	CS Matrona Antonia Mesa Fernández	Cabra, Córdoba
Spain	CS Olivillo	Cádiz
Spain	C.S. Callosa del Segura	Callosa De Segura, Alicante
Spain	C.S. Carballo	Carballo, A Coruña
Spain	CS Nuestra señora de Gracia	Carmona, Sevilla
Spain	CS Cartaya	Cartaya, Huelva
Spain	C.S. San Agustín	Castellón
Spain	CS Catarroja	Catarroja, Valencia
Spain	CAP Canaletas	Cerdanyola, Barcelona
Spain	CS Chapela	Chapela, Pontevedra
Spain	CS Ciudad Rodrigo	Ciudad Rodrigo Salamanca
Spain	CS Collado Villalba Estación	Collado Villalba, Madrid
Spain	CS Virgen de la Estrella 2	Coria Del Río, Sevilla
Spain	CS Jaime Vera	Coslada, Madrid
Spain	CS Cuenca IV	Cuenca
Spain	C.S. Cuntis	Cuntis, Pontevedra
Spain	Consultorio Guargacho	El Monte, Tenerife
Spain	CS Puerto de Santa María Sur	El Puerto De Santa María, Cádiz
Spain	CS San Miguel Basauri	Elexalde, Bizcaia
Spain	CAP Pubilla Casas	Esplugues De Llobregat, Barcelona
Spain	CS Lobillas	Estepona, Málaga
Spain	CS Favara	Favara, Valencia
Spain	CAP Figueres Ernest Lluch	Figueres, Girona
Spain	CAP Josep Masdevall	Figueres, Girona
Spain	CS Cuzco	Fuenlabrada, Madrid
Spain	CS Panaderas	Fuenlabrada, Madrid
Spain	CS Natahoyo	Gijón
Spain	CAP Montilivi	Girona
Spain	Consultorio Gorraiz	Gorráiz
Spain	CAP Hostalric	Hostalric, Girona
Spain	CS Huelva Centro	Huelva
Spain	CS Bulevar	Jaén
Spain	C.S. Jávea	Jávea, Alicante
Spain	CAP Bellvitge	L'Hospitalet De Llobregat, Barcelona
Spain	EAP - Centre - L´Hospitalet de Llobregat	L'Hospitalet De Llobregat, Barcelona
Spain	CS La Almunia de Doña Godina	La Almunia De Doña Godina, Zaragoza
Spain	CS La Bañeza II	La Bañeza, León
Spain	CS La Cañada	La Cañada, Almería
Spain	CS La Carlota	La Carlota, Córdoba
Spain	CS La Línea Poniente	La Línea De La Concepción, Cádiz
Spain	CS La Roda	La Roda, Albacete
Spain	CS Zubia	La Zubia, Granada
Spain	CS Laredo	Laredo, Cantabria
Spain	CS Las Cabezas de San Juan	Las Cabezas, Sevilla
Spain	CS Maspalomas	Las Palmas
Spain	CS San José	Las Palmas
Spain	CS Eras de Renueva	León
Spain	CS Loeches	Loeches, Madrid
Spain	CS Lora del Río Virgen de Setefilla	Lora Del Río, Sevilla
Spain	CS Los Barrios	Los Barrios, Cádiz
Spain	CS Lucena	Lucena, Córdoba
Spain	CS San Roque	Lugo
Spain	CS Abrantes	Madrid
Spain	CS Alcalá de Guadaira	Madrid
Spain	CS Aquitania	Madrid
Spain	CS Arroyo Media Legua	Madrid
Spain	CS Canal de Panamá	Madrid
Spain	CS Entrevias	Madrid
Spain	CS Estrecho de Corea	Madrid
Spain	CS General Fanjul	Madrid
Spain	CS Goya	Madrid
Spain	CS Las Aguilas	Madrid
Spain	CS Montesa	Madrid
Spain	CS Potosí	Madrid
Spain	CS Villa de Vallecas	Madrid
Spain	CS Villaamil	Madrid
Spain	CS Huelin	Málaga
Spain	CS Victoria	Málaga
Spain	CS Malagon	Malagon, Ciudad Real
Spain	CS Son Rullan	Mallorca
Spain	CS Mansilla de las Mulas	Mansilla De Las Mulas, León
Spain	C.M. Mataró	Mataró
Spain	CS Meliana	Meliana, Valencia
Spain	CS Mengibar	Mengibar, Jaén
Spain	CS Moguer	Moguer Huelva
Spain	CS Montoro	Montoro, Córdoba
Spain	CS dos de Mayo	Móstoles, Madrid
Spain	CS Dr. Luengo Rodríguez	Móstoles, Madrid
Spain	CS Neda	Neda, Coruña
Spain	CS Novelda	Novelda, Alicante
Spain	CS Orgiva	Orgiva, Granada
Spain	C.S. Osuna	Osuna, Sevilla
Spain	CS Jardinillos	Palencia
Spain	CS La Puebla	Palencia
Spain	CS Pintor Oliva	Palencia
Spain	CS Palos de la Frontera	Palos De La Frontera, Huelva
Spain	C.S. Parador	Parador De Las Hortichuelas, Almería
Spain	C. S. Paterna	Paterna, Valencia
Spain	CS Pedralba	Pedralba, Valencia
Spain	Consultorio Peñíscola	Peñíscola, Castellón
Spain	CS Pilas	Pilas, Sevilla
Spain	CS Polinya de Xuquer	Polinya De Xuquer, Valencia
Spain	CS Port de Pollença	Pollença, Baleares
Spain	CS Lérez	Pontevedra
Spain	CS Repelega	Portugalete, Bizkaia
Spain	CS Castaños	Portugalete, Vizcaya
Spain	CS Puebla de Cazalla	Puebla De Cazalla, Sevilla
Spain	CS Puerto Lumbreras	Puerto Lumbreras, Murcia
Spain	CS Puertollano I	Puertollano, Ciudad Real
Spain	CS Rute	Rute, Córdoba
Spain	CS Periurbana Sur	Salamanca
Spain	CS La Cuesta	San Cristóbal La Laguna, Tenerife
Spain	CS San Fernando Dr. Cayetano Roldán	San Fernando, Cádiz
Spain	C. S. San Juan	San Juán de Alicante
Spain	CS Sancti Spiritus	Sancti Spiritus, Salamanca
Spain	CS Sangüesa	Sangüesa, Navarra
Spain	CAP Montclar	Sant Boi De Llobregat, Barcelona
Spain	CAP Dr. Vilaseca	Santa Coloma Gramanet, Barcelona
Spain	CS El Doctoral	Santa Lucía De Tirajana, Las Palmas
Spain	CS Santa María del Camí	Santa Mª Del Camí, Baleares
Spain	CS Perello	Sueca, Valencia
Spain	CS Sueca	Sueca, Valencia
Spain	CS Tacoronte	Tacoronte, Tenerife
Spain	CS San Miguel de Abona	Tenerife
Spain	CS Titaguas	Titaguas, Valencia
Spain	CS Torredelcampo	Torre Del Campo, Jaén
Spain	CS Brújula	Torrejón De Ardoz Madrid
Spain	CS Covadonga	Torrelavega, Cantabria
Spain	CS Carihuela	Torremolinos, Málaga
Spain	CS Tudela Este	Tudela, Navarra
Spain	CS Valdefuentes	Valdefuentes, Cáceres
Spain	C.S. Malvarrosa	Valencia
Spain	CS Barrio de la Luz	Valencia
Spain	CS Campanar	Valencia
Spain	CS Ingeniero Joaquim Benlloch	Valencia
Spain	CS Vélez Norte	Vélez, Málaga
Spain	C.S. Coia Vigo	Vigo
Spain	CS La Doblada	Vigo
Spain	C. S. Almassera de Tonda, Vila Joiosa	Vila Joiosa, Alicante
Spain	CAP María Bernades	Viladecans, Barcelona
Spain	C. S. Xunqueira de Ambia	Xunqueira De Ambia, Ourense
Spain	CS Seminario	Zagaroza
Spain	CS Virgen de la Concha	Zamora
Spain	CS Canal Imperial Venecia	Zaragoza
Spain	CS Casablanca	Zaragoza
Spain	CS Fuentes Norte	Zaragoza
Spain	CS Seminario	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.

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