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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03611777
• Collaborator: (none)
• Enrollment: 901
• Locations: 169
• Actual Duration (Months): 17.6
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Inhaled corticosteroid

Study Design

• Study Type: Observational
• Actual Enrollment: 901 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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.
• Actual Study Start Date: Aug 14, 2018
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
subjects with Pulmonary Disease, Chronic Obstructive	Drug: Inhaled corticosteroid; Drug

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have 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).]

   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 Outcome Measures

1. 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).]

   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.

2. 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 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.

3. 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).]

   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.

4. 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.]

   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.

5. 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.]

   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.

6. 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).]

   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.

7. 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).]

   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.

8. Percentage of Patients With ICS-related Adverse Events [2 years prior to study visit, data collected at study visit (1 day).]

   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.

9. General Patient Profile - Body Mass Index (BMI) [2 years prior to study visit, data collected at study visit (1 day).]

   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.

10. 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 for patients treated with inhaled corticosteroids (ICS) and not treated with ICS. Number of patients by smoking habit (non-smoker, smoker, ex-smoker).

11. General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis [Data collected at study visit.]

    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).

12. 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 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.

13. 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 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.

14. 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 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.

15. General Patient Profile - COPD Assessment Test (CAT) Score [Data measured at study visit.]

    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.

16. General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score [Data measured at study visit.]

    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

17. General Patient Profile - Number of Patients by Level of Eosinophils [2 years prior to study visit, data collected at study visit (1 day).]

    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.

18. 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 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CS A Pontenova	A Pontenova, Lugo		Spain	27720
2	CAP Abrera	Abrera, Barcelona		Spain	8630
3	CS Zona VI	Albacete		Spain	2001
4	CS Zona IV	Albacete		Spain	2006
5	CS Nuestra Señora de la Oliva	Alcalá De Guadaira, Sevilla		Spain	41500
6	EAP Carmen Calzado	Alcalá De Henares, Madrid		Spain	28801
7	CS Alcasser	Alcasser, Valencia		Spain	46290
8	CS La Chopera	Alcobendas, Madrid		Spain	28100
9	CS Algeciras Norte	Algeciras, Cádiz		Spain	11205
10	CS Algemesi	Algemesi, Valencia		Spain	46680
11	CS Almonte	Almonte, Huelva		Spain	21730
12	Consultorio Alpuente	Alpuente, Valencia		Spain	46178
13	CS Argamasilla de Calatrava	Argamasilla De Calatrava, Ciudad Real		Spain	13440
14	CS Baltar Sanxenxo	Baltar, Pontevedra		Spain	36979
15	CAP Sant Marti (EAP Verneda Nord)	Barcelona		Spain	8020
16	CAP Sants	Barcelona		Spain	8028
17	EAP Vía Roma	Barcelona		Spain	8029
18	CAP Casernes	Barcelona		Spain	8030
19	CAP Chafarinas	Barcelona		Spain	8033
20	CAP Trinitat Vella	Barcelona		Spain	8033
21	Cap Sant Rafael	Barcelona		Spain	8035
22	CAP Casanova	Barcelona		Spain	8036
23	CAP Dr. Carles Ribas	Barcelona		Spain	8038
24	EAP Guinardo	Barcelona		Spain	8041
25	Consultorio Bañaderos	Bañaderos, Las Palmas		Spain	35414
26	CS Bedman	Bedman, Jaén		Spain	23537
27	Consultorio Médico Begíjar	Begíjar, Jaén		Spain	23520
28	CS Benigánim	Benigánim, Valencia		Spain	46830
29	C. S. Benimamet	Benimamet, Valencia		Spain	46035
30	CS Santutxu	Bilbao		Spain	48004
31	CS Comuneros	Burgos		Spain	9006
32	CS Gamonal Antigua	Burgos		Spain	9007
33	CS Matrona Antonia Mesa Fernández	Cabra, Córdoba		Spain	14940
34	C.S. Callosa del Segura	Callosa De Segura, Alicante		Spain	3360
35	C.S. Carballo	Carballo, A Coruña		Spain	15100
36	CS Nuestra señora de Gracia	Carmona, Sevilla		Spain	41410
37	CS Cartaya	Cartaya, Huelva		Spain	21450
38	C.S. San Agustín	Castellón		Spain	12004
39	CS Catarroja	Catarroja, Valencia		Spain	46470
40	CAP Canaletas	Cerdanyola, Barcelona		Spain	8290
41	CS Chapela	Chapela, Pontevedra		Spain	36320
42	CS Ciudad Rodrigo	Ciudad Rodrigo Salamanca		Spain	37500
43	CS Collado Villalba Estación	Collado Villalba, Madrid		Spain	28400
44	CS Virgen de la Estrella 2	Coria Del Río, Sevilla		Spain	41100
45	CS Jaime Vera	Coslada, Madrid		Spain	28821
46	CS Cuenca IV	Cuenca		Spain	16004
47	C.S. Cuntis	Cuntis, Pontevedra		Spain	36678
48	CS Olivillo	Cádiz		Spain	11001
49	Consultorio Guargacho	El Monte, Tenerife		Spain	38632
50	CS Puerto de Santa María Sur	El Puerto De Santa María, Cádiz		Spain	11500
51	CS San Miguel Basauri	Elexalde, Bizcaia		Spain	48970
52	CAP Pubilla Casas	Esplugues De Llobregat, Barcelona		Spain	8950
53	CS Lobillas	Estepona, Málaga		Spain	29680
54	CS Favara	Favara, Valencia		Spain	46614
55	CAP Figueres Ernest Lluch	Figueres, Girona		Spain	17600
56	CAP Josep Masdevall	Figueres, Girona		Spain	17600
57	CS Panaderas	Fuenlabrada, Madrid		Spain	28944
58	CS Cuzco	Fuenlabrada, Madrid		Spain	28945
59	CS Natahoyo	Gijón		Spain	33212
60	CAP Montilivi	Girona		Spain	17003
61	Consultorio Gorraiz	Gorráiz		Spain	31620
62	CAP Hostalric	Hostalric, Girona		Spain	17450
63	CS Huelva Centro	Huelva		Spain	21001
64	CS Bulevar	Jaén		Spain	23009
65	C.S. Jávea	Jávea, Alicante		Spain	3730
66	EAP - Centre - L´Hospitalet de Llobregat	L'Hospitalet De Llobregat, Barcelona		Spain	8901
67	CAP Bellvitge	L'Hospitalet De Llobregat, Barcelona		Spain	8907
68	CS La Almunia de Doña Godina	La Almunia De Doña Godina, Zaragoza		Spain	50100
69	CS La Bañeza II	La Bañeza, León		Spain	24750
70	CS La Carlota	La Carlota, Córdoba		Spain	14100
71	CS La Cañada	La Cañada, Almería		Spain	4120
72	CS La Línea Poniente	La Línea De La Concepción, Cádiz		Spain	11300
73	CS La Roda	La Roda, Albacete		Spain	2630
74	CS Zubia	La Zubia, Granada		Spain	18140
75	CS Laredo	Laredo, Cantabria		Spain	39770
76	CS Las Cabezas de San Juan	Las Cabezas, Sevilla		Spain	41730
77	CS San José	Las Palmas		Spain	35016
78	CS Maspalomas	Las Palmas		Spain	35109
79	CS Eras de Renueva	León		Spain	24008
80	CS Loeches	Loeches, Madrid		Spain	28890
81	CS Lora del Río Virgen de Setefilla	Lora Del Río, Sevilla		Spain	41440
82	CS Los Barrios	Los Barrios, Cádiz		Spain	11370
83	CS Lucena	Lucena, Córdoba		Spain	14900
84	CS San Roque	Lugo		Spain	27002
85	CS Montesa	Madrid		Spain	28006
86	CS Goya	Madrid		Spain	28009
87	CS Potosí	Madrid		Spain	28016
88	CS Alcalá de Guadaira	Madrid		Spain	28018
89	CS Abrantes	Madrid		Spain	28025
90	CS Canal de Panamá	Madrid		Spain	28027
91	CS Estrecho de Corea	Madrid		Spain	28027
92	CS Arroyo Media Legua	Madrid		Spain	28030
93	CS Villa de Vallecas	Madrid		Spain	28031
94	CS Aquitania	Madrid		Spain	28032
95	CS Villaamil	Madrid		Spain	28039
96	CS General Fanjul	Madrid		Spain	28044
97	CS Las Aguilas	Madrid		Spain	28044
98	CS Entrevias	Madrid		Spain	28053
99	CS Malagon	Malagon, Ciudad Real		Spain	13420
100	CS Son Rullan	Mallorca		Spain	7009
101	CS Mansilla de las Mulas	Mansilla De Las Mulas, León		Spain	24210
102	C.M. Mataró	Mataró		Spain	8301
103	CS Meliana	Meliana, Valencia		Spain	46133
104	CS Mengibar	Mengibar, Jaén		Spain	23620
105	CS Moguer	Moguer Huelva		Spain	21800
106	CS Montoro	Montoro, Córdoba		Spain	14600
107	CS Huelin	Málaga		Spain	29002
108	CS Victoria	Málaga		Spain	29013
109	CS dos de Mayo	Móstoles, Madrid		Spain	28934
110	CS Dr. Luengo Rodríguez	Móstoles, Madrid		Spain	28938
111	CS Neda	Neda, Coruña		Spain	15510
112	CS Novelda	Novelda, Alicante		Spain	3660
113	CS Orgiva	Orgiva, Granada		Spain	18400
114	C.S. Osuna	Osuna, Sevilla		Spain	41640
115	CS Jardinillos	Palencia		Spain	34001
116	CS La Puebla	Palencia		Spain	34002
117	CS Pintor Oliva	Palencia		Spain	34004
118	CS Palos de la Frontera	Palos De La Frontera, Huelva		Spain	21810
119	C.S. Parador	Parador De Las Hortichuelas, Almería		Spain	4720
120	C. S. Paterna	Paterna, Valencia		Spain	46980
121	CS Pedralba	Pedralba, Valencia		Spain	46164
122	Consultorio Peñíscola	Peñíscola, Castellón		Spain	12598
123	CS Pilas	Pilas, Sevilla		Spain	41840
124	CS Polinya de Xuquer	Polinya De Xuquer, Valencia		Spain	46688
125	CS Port de Pollença	Pollença, Baleares		Spain	7470
126	CS Lérez	Pontevedra		Spain	36156
127	CS Repelega	Portugalete, Bizkaia		Spain	48920
128	CS Castaños	Portugalete, Vizcaya		Spain	48920
129	CS Puebla de Cazalla	Puebla De Cazalla, Sevilla		Spain	41540
130	CS Puerto Lumbreras	Puerto Lumbreras, Murcia		Spain	30890
131	CS Puertollano I	Puertollano, Ciudad Real		Spain	13500
132	CS Rute	Rute, Córdoba		Spain	14960
133	CS Periurbana Sur	Salamanca		Spain	37008
134	CS La Cuesta	San Cristóbal La Laguna, Tenerife		Spain	38320
135	CS San Fernando Dr. Cayetano Roldán	San Fernando, Cádiz		Spain	11100
136	C. S. San Juan	San Juán de Alicante		Spain	3550
137	CS Sancti Spiritus	Sancti Spiritus, Salamanca		Spain	37470
138	CS Sangüesa	Sangüesa, Navarra		Spain	31400
139	CAP Montclar	Sant Boi De Llobregat, Barcelona		Spain	8830
140	CAP Dr. Vilaseca	Santa Coloma Gramanet, Barcelona		Spain	8921
141	CS El Doctoral	Santa Lucía De Tirajana, Las Palmas		Spain	35110
142	CS Santa María del Camí	Santa Mª Del Camí, Baleares		Spain	7320
143	CS Perello	Sueca, Valencia		Spain	46410
144	CS Sueca	Sueca, Valencia		Spain	46410
145	CS Tacoronte	Tacoronte, Tenerife		Spain	38350
146	CS San Miguel de Abona	Tenerife		Spain	38620
147	CS Titaguas	Titaguas, Valencia		Spain	46178
148	CS Torredelcampo	Torre Del Campo, Jaén		Spain	23640
149	CS Brújula	Torrejón De Ardoz Madrid		Spain	28850
150	CS Covadonga	Torrelavega, Cantabria		Spain	39300
151	CS Carihuela	Torremolinos, Málaga		Spain	29620
152	CS Tudela Este	Tudela, Navarra		Spain	31500
153	CS Valdefuentes	Valdefuentes, Cáceres		Spain	10180
154	CS Ingeniero Joaquim Benlloch	Valencia		Spain	46006
155	C.S. Malvarrosa	Valencia		Spain	46011
156	CS Barrio de la Luz	Valencia		Spain	46014
157	CS Campanar	Valencia		Spain	46015
158	CS La Doblada	Vigo		Spain	36205
159	C.S. Coia Vigo	Vigo		Spain	36209
160	C. S. Almassera de Tonda, Vila Joiosa	Vila Joiosa, Alicante		Spain	3570
161	CAP María Bernades	Viladecans, Barcelona		Spain	8840
162	CS Vélez Norte	Vélez, Málaga		Spain	29700
163	C. S. Xunqueira de Ambia	Xunqueira De Ambia, Ourense		Spain	32670
164	CS Seminario	Zagaroza		Spain	50009
165	CS Virgen de la Concha	Zamora		Spain	49022
166	CS Fuentes Norte	Zaragoza		Spain	50002
167	CS Canal Imperial Venecia	Zaragoza		Spain	50006
168	CS Casablanca	Zaragoza		Spain	50009
169	CS Seminario	Zaragoza		Spain	50009

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Mireia Canals, ([phone], [e-mail]

Study Documents (Full-Text)

• Study Protocol - Sep 19, 2017
• Statistical Analysis Plan - May 29, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03611777
• Other Study ID Numbers: 1237-0070
• First Posted: Aug 2, 2018
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Recruitment Details	Non-interventional, cross-sectional, multicenter study to describe the chronic obstructive pulmonary disease (COPD) patient profile of patients treated with or without Inhaled CorticoSteroids (ICS) in primary care, in Spain.
Pre-assignment Detail	Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Period Title: Overall Study
STARTED	432	469
COMPLETED	432	469
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit	Total
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).	Total of all reporting groups
Overall Participants	432	469	901
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	71.44 (10.27)	70.55 (9.37)	70.97 (9.82)
Sex: Female, Male (Count of Participants)
Female	89 20.6%	88 18.8%	177 19.6%
Male	343 79.4%	381 81.2%	724 80.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	427 98.8%	467 99.6%	894 99.2%
African	3 0.7%	1 0.2%	4 0.4%
Argentinian	0 0%	1 0.2%	1 0.1%
Gypsy	1 0.2%	0 0%	1 0.1%
Unknown	1 0.2%	0 0%	1 0.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were treated with ICS at study visit.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432
Number (95% Confidence Interval) [Percentage of participants]	62.5 14.5%

2. Secondary Outcome

Title	Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit
Description	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.
Time Frame	1 year prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were treated with ICS at study visit.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432
Number (95% Confidence Interval) [Percentage of participants]	37.5 8.7%

3. Secondary Outcome

Title	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
Description	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.
Time Frame	2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were treated with ICS at study visit.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432
With moderate or severe exacerbations	46.8 10.8%
Without moderate or severe exacerbations	53.2 12.3%

4. Secondary Outcome

Title	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
Description	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.
Time Frame	1 year and 2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were not treated with ICS at study visit.

Arm/Group Title	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	469
1 year prior study visit: With moderate or severe exacerbations	16.6 3.8%
1 year prior study visit: Without moderate or severe exacerbations	83.4 19.3%
2 years prior study visit: With moderate or severe exacerbation	22.8 5.3%
2 years prior study visit: Without moderate or severe exacerbations	77.2 17.9%

5. Secondary Outcome

Title	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
Description	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.
Time Frame	1 year and 2 years prior to study visit, data collected at study visit.

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were treated with ICS at study visit.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432
1 year prior study visit	0.72 (1.23)
2 years prior to study visit	1.27 (1.99)

6. Secondary Outcome

Title	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
Description	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.
Time Frame	1 year and 2 years prior to study visit, data collected at study visit.

Outcome Measure Data

Analysis Population Description

Patients in the FAS who were not treated with ICS at study visit.

Arm/Group Title	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	469
1 year prior study visit	0.26 (0.77)
2 years prior study visit	0.43 (1.25)

7. Secondary Outcome

Title	Percentage of Patients Using Rescue Medication
Description	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.
Time Frame	1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Not Treated With ICS at Study Visit	COPD Patients Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	469	432
Last 2 years: Use of rescue medication (overall)	43.9 10.2%	65.7 14%
Last 2 years: Rescue Medication - SABA	35.4 8.2%	58.6 12.5%
Last 2 years: Rescue Medication - SABA[*] (including salbutamol in combinations)	35.4 8.2%	58.8 12.5%
Last 2 years: Rescue Medication - Others	10.0 2.3%	12.3 2.6%
Last 2 years: R03AC: Selective Beta-2-Adrenoreceptor Agonists	35.6 8.2%	58.6 12.5%
Last 2 years: R03BB: Anticholinergics	9.2 2.1%	10.9 2.3%
Last year: Use of rescue medication (overall)	41.4 9.6%	63.9 13.6%
Last year: Rescue medication - SABA	33.0 7.6%	56.9 12.1%
Last year: Rescue medication - SABA[*] (including salbutamol in combinations)	33.0 7.6%	57.2 12.2%
Last year: Rescue medication - Others	9.6 2.2%	11.3 2.4%
Last year: R03AC: Selective Beta-2-Adrenoreceptor Agonists	33.0 7.6%	56.9 12.1%
Last year: R03BB: Anticholinergics	9.0 2.1%	10.0 2.1%

8. Secondary Outcome

Title	Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
Description	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.
Time Frame	1 year prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available type of risk and phenotype (n=877).

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	415	462
Adherence	150 34.7%	423 90.2%
Non-Adherence	265 61.3%	39 8.3%
Adherence	0 0%	214 45.6%
Non-Adherence	112 25.9%	0 0%
Adherence	150 34.7%	209 44.6%
Non-Adherence	153 35.4%	39 8.3%

9. Secondary Outcome

Title	Percentage of Patients With ICS-related Adverse Events
Description	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.
Time Frame	2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	Patients With COPD - Overall
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD), with or without current treatment of Inhaled CorticoSteroids (ICS) at study visit.
Measure Participants	901
Number [Percentage of Participants]	1.55 0.4%

10. Secondary Outcome

Title	General Patient Profile - Body Mass Index (BMI)
Description	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.
Time Frame	2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available data for this endpoint.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	407	446
Mean (Standard Deviation) [Kg/m^2]	28.38 (5.26)	28.37 (5.11)

11. Secondary Outcome

Title	General Patient Profile - Number of Patients by Smoking Habit
Description	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).
Time Frame	2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available data for this endpoint.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	430	469
Non-smoker	36 8.3%	42 9%
Smoker	124 28.7%	157 33.5%
Ex-smoker	270 62.5%	270 57.6%

12. Secondary Outcome

Title	General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis
Description	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).
Time Frame	Data collected at study visit.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432	469
Mean (Standard Deviation) [Years]	10.19 (6.10)	8.93 (5.48)

13. Secondary Outcome

Title	General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
Description	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.
Time Frame	2 years prior to study visit, auto-calculated at study visit.

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available data for this endpoint.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	307	326
Gold I - Mild	57 13.2%	85 18.1%
Gold II - Moderate	164 38%	194 41.4%
Gold III - Severe	75 17.4%	42 9%
Gold IV - Very Severe	11 2.5%	5 1.1%

14. Secondary Outcome

Title	General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
Description	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.
Time Frame	2 years prior to study visit, auto-calculated at study visit.

Outcome Measure Data

Analysis Population Description

Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432	469
Group A	39 9%	54 11.5%
Group B	224 51.9%	330 70.4%
Group C	3 0.7%	6 1.3%
Group D	166 38.4%	79 16.8%

15. Secondary Outcome

Title	General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index
Description	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.
Time Frame	2 years prior to study visit, auto-calculated at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available data for this endpoint.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	297	315
Mean (Standard Deviation) [Score on a scale]	1.93 (1.72)	1.15 (1.21)

16. Secondary Outcome

Title	General Patient Profile - COPD Assessment Test (CAT) Score
Description	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.
Time Frame	Data measured at study visit.

Outcome Measure Data

Analysis Population Description

Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432	469
Mean (Standard Deviation) [Score on a scale]	16.06 (8.03)	12.96 (7.25)

17. Secondary Outcome

Title	General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Description	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
Time Frame	Data measured at study visit.

Outcome Measure Data

Analysis Population Description

Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432	469
Grade 0	58 13.4%	93 19.8%
Grade 1	142 32.9%	199 42.4%
Grade 2	133 30.8%	130 27.7%
Grade 3	70 16.2%	44 9.4%
Grade 4	29 6.7%	3 0.6%

18. Secondary Outcome

Title	General Patient Profile - Number of Patients by Level of Eosinophils
Description	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.
Time Frame	2 years prior to study visit, data collected at study visit (1 day).

Outcome Measure Data

Analysis Population Description

Patients in the FAS with available data for this endpoint.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
Measure Participants	304	328
Low number of eosinophils	208 48.1%	242 51.6%
High number of eosinophils	96 22.2%	86 18.3%

19. Secondary Outcome

Title	General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
Description	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.
Time Frame	2 years prior to study visit, data collected at study visit.

Outcome Measure Data

Analysis Population Description

Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.

Arm/Group Title	COPD Patients Treated With ICS at Study Visit	COPD Patients Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
Measure Participants	432	469
Without treatment	0 0%	46 9.8%
SABA alone	0 0%	6 1.3%
SAMA alone	0 0%	5 1.1%
SABA + SAMA	0 0%	0 0%
LABA alone	0 0%	3 0.6%
LAMA alone	0 0%	93 19.8%
ICS alone	5 1.2%	0 0%
LABA + LAMA	0 0%	316 67.4%
LABA + ICS	106 24.5%	0 0%
LAMA + ICS	4 0.9%	0 0%
LABA + LAMA + ICS	317 73.4%	0 0%

Adverse Events

Time Frame	Within 2 years prior to the study visit, up to 2 years.
Adverse Event Reporting Description	The study design is of non-interventional nature and the study is conducted within the conditions of the approved marketing authorizations. As no investigational product was used, but patients could have been treated with BI drugs, adverse events were reported on the safety analysis set, which included all enrolled patients treated with at least on dose of SPIOLTO®, STRIVERDI®, SPIRIVA® or ATROVENT® during the study period. Adverse events were reported as single arm align with the study design.
Arm/Group Title	COPD Patients Treated or Not Treated With ICS at Study Visit
Arm/Group Description	Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated or not treated with Inhaled CorticoSteroids (ICS).
All Cause Mortality
	COPD Patients Treated or Not Treated With ICS at Study Visit
	Affected / at Risk (%)	# Events
Total	0/441 (0%)
Serious Adverse Events
	COPD Patients Treated or Not Treated With ICS at Study Visit
	Affected / at Risk (%)	# Events
Total	0/441 (0%)
Other (Not Including Serious) Adverse Events
	COPD Patients Treated or Not Treated With ICS at Study Visit
	Affected / at Risk (%)	# Events
Total	0/441 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.