Clinical trial NCT03611777: The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 901
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study will be conducted with COPD patients attended at Spanish Primary Care offices.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit
timeFrame: 1 year prior to study visit, data collected at study visit (1 day).
Secondary outcomes:
measure: Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit
timeFrame: 1 year prior to study visit, data collected at study visit (1 day).
measure: 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
timeFrame: 2 years prior to study visit, data collected at study visit (1 day).
measure: 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
timeFrame: 1 year and 2 years prior to study visit, data collected at study visit (1 day).
measure: 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
timeFrame: 1 year and 2 years prior to study visit, data collected at study visit.
measure: 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
timeFrame: 1 year and 2 years prior to study visit, data collected at study visit.
measure: Percentage of Patients Using Rescue Medication
timeFrame: 1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).
measure: Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
timeFrame: 1 year prior to study visit, data collected at study visit (1 day).
measure: Percentage of Patients With ICS-related Adverse Events
timeFrame: 2 years prior to study visit, data collected at study visit (1 day).
measure: General Patient Profile - Body Mass Index (BMI)
timeFrame: 2 years prior to study visit, data collected at study visit (1 day).
measure: General Patient Profile - Number of Patients by Smoking Habit
timeFrame: 2 years prior to study visit, data collected at study visit (1 day).
measure: General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis
timeFrame: Data collected at study visit.
measure: General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
timeFrame: 2 years prior to study visit, auto-calculated at study visit.
measure: General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
timeFrame: 2 years prior to study visit, auto-calculated at study visit.
measure: General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index
timeFrame: 2 years prior to study visit, auto-calculated at study visit (1 day).
measure: General Patient Profile - COPD Assessment Test (CAT) Score
timeFrame: Data measured at study visit.
measure: General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
timeFrame: Data measured at study visit.
measure: General Patient Profile - Number of Patients by Level of Eosinophils
timeFrame: 2 years prior to study visit, data collected at study visit (1 day).
measure: General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
timeFrame: 2 years prior to study visit, data collected at study visit.
Other outcomes:
Locations:
city: A Pontenova, Lugo
country: Spain
facility: CS A Pontenova
city: Abrera, Barcelona
country: Spain
facility: CAP Abrera
city: Albacete
country: Spain
facility: CS Zona VI
city: Albacete
country: Spain
facility: CS Zona IV
city: Alcalá De Guadaira, Sevilla
country: Spain
facility: CS Nuestra Señora de la Oliva
city: Alcalá De Henares, Madrid
country: Spain
facility: EAP Carmen Calzado
city: Alcasser, Valencia
country: Spain
facility: CS Alcasser
city: Alcobendas, Madrid
country: Spain
facility: CS La Chopera
city: Algeciras, Cádiz
country: Spain
facility: CS Algeciras Norte
city: Algemesi, Valencia
country: Spain
facility: CS Algemesi
city: Almonte, Huelva
country: Spain
facility: CS Almonte
city: Alpuente, Valencia
country: Spain
facility: Consultorio Alpuente
city: Argamasilla De Calatrava, Ciudad Real
country: Spain
facility: CS Argamasilla de Calatrava
city: Baltar, Pontevedra
country: Spain
facility: CS Baltar Sanxenxo
city: Barcelona
country: Spain
facility: CAP Sant Marti (EAP Verneda Nord)
city: Barcelona
country: Spain
facility: CAP Sants
city: Barcelona
country: Spain
facility: EAP Vía Roma
city: Barcelona
country: Spain
facility: CAP Casernes
city: Barcelona
country: Spain
facility: CAP Chafarinas
city: Barcelona
country: Spain
facility: CAP Trinitat Vella
city: Barcelona
country: Spain
facility: Cap Sant Rafael
city: Barcelona
country: Spain
facility: CAP Casanova
city: Barcelona
country: Spain
facility: CAP Dr. Carles Ribas
city: Barcelona
country: Spain
facility: EAP Guinardo
city: Bañaderos, Las Palmas
country: Spain
facility: Consultorio Bañaderos
city: Bedman, Jaén
country: Spain
facility: CS Bedman
city: Begíjar, Jaén
country: Spain
facility: Consultorio Médico Begíjar
city: Benigánim, Valencia
country: Spain
facility: CS Benigánim
city: Benimamet, Valencia
country: Spain
facility: C. S. Benimamet
city: Bilbao
country: Spain
facility: CS Santutxu
city: Burgos
country: Spain
facility: CS Comuneros
city: Burgos
country: Spain
facility: CS Gamonal Antigua
city: Cabra, Córdoba
country: Spain
facility: CS Matrona Antonia Mesa Fernández
city: Callosa De Segura, Alicante
country: Spain
facility: C.S. Callosa del Segura
city: Carballo, A Coruña
country: Spain
facility: C.S. Carballo
city: Carmona, Sevilla
country: Spain
facility: CS Nuestra señora de Gracia
city: Cartaya, Huelva
country: Spain
facility: CS Cartaya
city: Castellón
country: Spain
facility: C.S. San Agustín
city: Catarroja, Valencia
country: Spain
facility: CS Catarroja
city: Cerdanyola, Barcelona
country: Spain
facility: CAP Canaletas
city: Chapela, Pontevedra
country: Spain
facility: CS Chapela
city: Ciudad Rodrigo Salamanca
country: Spain
facility: CS Ciudad Rodrigo
city: Collado Villalba, Madrid
country: Spain
facility: CS Collado Villalba Estación
city: Coria Del Río, Sevilla
country: Spain
facility: CS Virgen de la Estrella 2
city: Coslada, Madrid
country: Spain
facility: CS Jaime Vera
city: Cuenca
country: Spain
facility: CS Cuenca IV
city: Cuntis, Pontevedra
country: Spain
facility: C.S. Cuntis
city: Cádiz
country: Spain
facility: CS Olivillo
city: El Monte, Tenerife
country: Spain
facility: Consultorio Guargacho
city: El Puerto De Santa María, Cádiz
country: Spain
facility: CS Puerto de Santa María Sur
city: Elexalde, Bizcaia
country: Spain
facility: CS San Miguel Basauri
city: Esplugues De Llobregat, Barcelona
country: Spain
facility: CAP Pubilla Casas
city: Estepona, Málaga
country: Spain
facility: CS Lobillas
city: Favara, Valencia
country: Spain
facility: CS Favara
city: Figueres, Girona
country: Spain
facility: CAP Figueres Ernest Lluch
city: Figueres, Girona
country: Spain
facility: CAP Josep Masdevall
city: Fuenlabrada, Madrid
country: Spain
facility: CS Panaderas
city: Fuenlabrada, Madrid
country: Spain
facility: CS Cuzco
city: Gijón
country: Spain
facility: CS Natahoyo
city: Girona
country: Spain
facility: CAP Montilivi
city: Gorráiz
country: Spain
facility: Consultorio Gorraiz
city: Hostalric, Girona
country: Spain
facility: CAP Hostalric
city: Huelva
country: Spain
facility: CS Huelva Centro
city: Jaén
country: Spain
facility: CS Bulevar
city: Jávea, Alicante
country: Spain
facility: C.S. Jávea
city: L'Hospitalet De Llobregat, Barcelona
country: Spain
facility: EAP - Centre - L´Hospitalet de Llobregat
city: L'Hospitalet De Llobregat, Barcelona
country: Spain
facility: CAP Bellvitge
city: La Almunia De Doña Godina, Zaragoza
country: Spain
facility: CS La Almunia de Doña Godina
city: La Bañeza, León
country: Spain
facility: CS La Bañeza II
city: La Carlota, Córdoba
country: Spain
facility: CS La Carlota
city: La Cañada, Almería
country: Spain
facility: CS La Cañada
city: La Línea De La Concepción, Cádiz
country: Spain
facility: CS La Línea Poniente
city: La Roda, Albacete
country: Spain
facility: CS La Roda
city: La Zubia, Granada
country: Spain
facility: CS Zubia
city: Laredo, Cantabria
country: Spain
facility: CS Laredo
city: Las Cabezas, Sevilla
country: Spain
facility: CS Las Cabezas de San Juan
city: Las Palmas
country: Spain
facility: CS San José
city: Las Palmas
country: Spain
facility: CS Maspalomas
city: León
country: Spain
facility: CS Eras de Renueva
city: Loeches, Madrid
country: Spain
facility: CS Loeches
city: Lora Del Río, Sevilla
country: Spain
facility: CS Lora del Río Virgen de Setefilla
city: Los Barrios, Cádiz
country: Spain
facility: CS Los Barrios
city: Lucena, Córdoba
country: Spain
facility: CS Lucena
city: Lugo
country: Spain
facility: CS San Roque
city: Madrid
country: Spain
facility: CS Montesa
city: Madrid
country: Spain
facility: CS Goya
city: Madrid
country: Spain
facility: CS Potosí
city: Madrid
country: Spain
facility: CS Alcalá de Guadaira
city: Madrid
country: Spain
facility: CS Abrantes
city: Madrid
country: Spain
facility: CS Canal de Panamá
city: Madrid
country: Spain
facility: CS Estrecho de Corea
city: Madrid
country: Spain
facility: CS Arroyo Media Legua
city: Madrid
country: Spain
facility: CS Villa de Vallecas
city: Madrid
country: Spain
facility: CS Aquitania
city: Madrid
country: Spain
facility: CS Villaamil
city: Madrid
country: Spain
facility: CS General Fanjul
city: Madrid
country: Spain
facility: CS Las Aguilas
city: Madrid
country: Spain
facility: CS Entrevias
city: Malagon, Ciudad Real
country: Spain
facility: CS Malagon
city: Mallorca
country: Spain
facility: CS Son Rullan
city: Mansilla De Las Mulas, León
country: Spain
facility: CS Mansilla de las Mulas
city: Mataró
country: Spain
facility: C.M. Mataró
city: Meliana, Valencia
country: Spain
facility: CS Meliana
city: Mengibar, Jaén
country: Spain
facility: CS Mengibar
city: Moguer Huelva
country: Spain
facility: CS Moguer
city: Montoro, Córdoba
country: Spain
facility: CS Montoro
city: Málaga
country: Spain
facility: CS Huelin
city: Málaga
country: Spain
facility: CS Victoria
city: Móstoles, Madrid
country: Spain
facility: CS dos de Mayo
city: Móstoles, Madrid
country: Spain
facility: CS Dr. Luengo Rodríguez
city: Neda, Coruña
country: Spain
facility: CS Neda
city: Novelda, Alicante
country: Spain
facility: CS Novelda
city: Orgiva, Granada
country: Spain
facility: CS Orgiva
city: Osuna, Sevilla
country: Spain
facility: C.S. Osuna
city: Palencia
country: Spain
facility: CS Jardinillos
city: Palencia
country: Spain
facility: CS La Puebla
city: Palencia
country: Spain
facility: CS Pintor Oliva
city: Palos De La Frontera, Huelva
country: Spain
facility: CS Palos de la Frontera
city: Parador De Las Hortichuelas, Almería
country: Spain
facility: C.S. Parador
city: Paterna, Valencia
country: Spain
facility: C. S. Paterna
city: Pedralba, Valencia
country: Spain
facility: CS Pedralba
city: Peñíscola, Castellón
country: Spain
facility: Consultorio Peñíscola
city: Pilas, Sevilla
country: Spain
facility: CS Pilas
city: Polinya De Xuquer, Valencia
country: Spain
facility: CS Polinya de Xuquer
city: Pollença, Baleares
country: Spain
facility: CS Port de Pollença
city: Pontevedra
country: Spain
facility: CS Lérez
city: Portugalete, Bizkaia
country: Spain
facility: CS Repelega
city: Portugalete, Vizcaya
country: Spain
facility: CS Castaños
city: Puebla De Cazalla, Sevilla
country: Spain
facility: CS Puebla de Cazalla
city: Puerto Lumbreras, Murcia
country: Spain
facility: CS Puerto Lumbreras
city: Puertollano, Ciudad Real
country: Spain
facility: CS Puertollano I
city: Rute, Córdoba
country: Spain
facility: CS Rute
city: Salamanca
country: Spain
facility: CS Periurbana Sur
city: San Cristóbal La Laguna, Tenerife
country: Spain
facility: CS La Cuesta
city: San Fernando, Cádiz
country: Spain
facility: CS San Fernando Dr. Cayetano Roldán
city: San Juán de Alicante
country: Spain
facility: C. S. San Juan
city: Sancti Spiritus, Salamanca
country: Spain
facility: CS Sancti Spiritus
city: Sangüesa, Navarra
country: Spain
facility: CS Sangüesa
city: Sant Boi De Llobregat, Barcelona
country: Spain
facility: CAP Montclar
city: Santa Coloma Gramanet, Barcelona
country: Spain
facility: CAP Dr. Vilaseca
city: Santa Lucía De Tirajana, Las Palmas
country: Spain
facility: CS El Doctoral
city: Santa Mª Del Camí, Baleares
country: Spain
facility: CS Santa María del Camí
city: Sueca, Valencia
country: Spain
facility: CS Perello
city: Sueca, Valencia
country: Spain
facility: CS Sueca
city: Tacoronte, Tenerife
country: Spain
facility: CS Tacoronte
city: Tenerife
country: Spain
facility: CS San Miguel de Abona
city: Titaguas, Valencia
country: Spain
facility: CS Titaguas
city: Torre Del Campo, Jaén
country: Spain
facility: CS Torredelcampo
city: Torrejón De Ardoz Madrid
country: Spain
facility: CS Brújula
city: Torrelavega, Cantabria
country: Spain
facility: CS Covadonga
city: Torremolinos, Málaga
country: Spain
facility: CS Carihuela
city: Tudela, Navarra
country: Spain
facility: CS Tudela Este
city: Valdefuentes, Cáceres
country: Spain
facility: CS Valdefuentes
city: Valencia
country: Spain
facility: CS Ingeniero Joaquim Benlloch
city: Valencia
country: Spain
facility: C.S. Malvarrosa
city: Valencia
country: Spain
facility: CS Barrio de la Luz
city: Valencia
country: Spain
facility: CS Campanar
city: Vigo
country: Spain
facility: CS La Doblada
city: Vigo
country: Spain
facility: C.S. Coia Vigo
city: Vila Joiosa, Alicante
country: Spain
facility: C. S. Almassera de Tonda, Vila Joiosa
city: Viladecans, Barcelona
country: Spain
facility: CAP María Bernades
city: Vélez, Málaga
country: Spain
facility: CS Vélez Norte
city: Xunqueira De Ambia, Ourense
country: Spain
facility: C. S. Xunqueira de Ambia
city: Zagaroza
country: Spain
facility: CS Seminario
city: Zamora
country: Spain
facility: CS Virgen de la Concha
city: Zaragoza
country: Spain
facility: CS Fuentes Norte
city: Zaragoza
country: Spain
facility: CS Canal Imperial Venecia
city: Zaragoza
country: Spain
facility: CS Casablanca
city: Zaragoza
country: Spain
facility: CS Seminario
Study officials:
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia Canals, (+34) 93 404 58 77
role: STUDY_CHAIR
References: