The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.
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.
1 other identifier
observational
901
1 country
169
Brief Summary
This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedResults Posted
Study results publicly available
February 17, 2021
CompletedApril 8, 2021
March 1, 2021
1.5 years
July 2, 2018
January 27, 2021
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (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
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 Outcomes (18)
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 Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, in the Previous 2 Years Before the Study Visit
2 years prior to study visit, data collected at study visit (1 day).
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit
1 year and 2 years prior to study visit, data collected at study visit (1 day).
Number of Moderate or Severe Exacerbations in Patients 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 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.
- +13 more secondary outcomes
Study Arms (1)
subjects with Pulmonary Disease, Chronic Obstructive
Interventions
Eligibility Criteria
study will be conducted with COPD patients attended at Spanish Primary Care offices.
You may qualify if:
- Written informed consent prior to participation
- Female and male patient ≥ 40 years of age
- Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
- Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio \<70%)
- Clinical data available 2 years before the study visit
- Ability to complete CAT - COPD Assessment Test
You may not qualify if:
- Current participation in any clinical trial involving a drug or device
- A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (169)
CS A Pontenova
A Pontenova, Lugo, 27720, Spain
CAP Abrera
Abrera, Barcelona, 8630, Spain
CS Zona VI
Albacete, 2001, Spain
CS Zona IV
Albacete, 2006, Spain
CS Nuestra Señora de la Oliva
Alcalá de Guadaira, Sevilla, 41500, Spain
EAP Carmen Calzado
Alcalá de Henares, Madrid, 28801, Spain
CS Alcasser
Alcasser, Valencia, 46290, Spain
CS La Chopera
Alcobendas, Madrid, 28100, Spain
CS Algeciras Norte
Algeciras, Cádiz, 11205, Spain
CS Algemesi
Algemesi, Valencia, 46680, Spain
CS Almonte
Almonte, Huelva, 21730, Spain
Consultorio Alpuente
Alpuente, Valencia, 46178, Spain
CS Argamasilla de Calatrava
Argamasilla de Calatrava, Ciudad Real, 13440, Spain
CS Baltar Sanxenxo
Baltar, Pontevedra, 36979, Spain
Consultorio Bañaderos
Bañaderos, Las Palmas, 35414, Spain
CAP Sant Marti (EAP Verneda Nord)
Barcelona, 8020, Spain
CAP Sants
Barcelona, 8028, Spain
EAP Vía Roma
Barcelona, 8029, Spain
CAP Casernes
Barcelona, 8030, Spain
CAP Chafarinas
Barcelona, 8033, Spain
CAP Trinitat Vella
Barcelona, 8033, Spain
Cap Sant Rafael
Barcelona, 8035, Spain
CAP Casanova
Barcelona, 8036, Spain
CAP Dr. Carles Ribas
Barcelona, 8038, Spain
EAP Guinardo
Barcelona, 8041, Spain
CS Bedman
Bedman, Jaén, 23537, Spain
Consultorio Médico Begíjar
Begíjar, Jaén, 23520, Spain
CS Benigánim
Benigánim, Valencia, 46830, Spain
C. S. Benimamet
Benimamet, Valencia, 46035, Spain
CS Santutxu
Bilbao, 48004, Spain
CS Comuneros
Burgos, 9006, Spain
CS Gamonal Antigua
Burgos, 9007, Spain
CS Matrona Antonia Mesa Fernández
Cabra, Córdoba, 14940, Spain
CS Olivillo
Cadiz, 11001, Spain
C.S. Callosa del Segura
Callosa de Segura, Alicante, 3360, Spain
C.S. Carballo
Carballo, A Coruña, 15100, Spain
CS Nuestra señora de Gracia
Carmona, Sevilla, 41410, Spain
CS Cartaya
Cartaya, Huelva, 21450, Spain
C.S. San Agustín
Castellon, 12004, Spain
CS Catarroja
Catarroja, Valencia, 46470, Spain
CAP Canaletas
Cerdanyola, Barcelona, 8290, Spain
CS Chapela
Chapela, Pontevedra, 36320, Spain
CS Ciudad Rodrigo
Ciudad Rodrigo Salamanca, 37500, Spain
CS Collado Villalba Estación
Collado Villalba, Madrid, 28400, Spain
CS Virgen de la Estrella 2
Coria Del Río, Sevilla, 41100, Spain
CS Jaime Vera
Coslada, Madrid, 28821, Spain
CS Cuenca IV
Cuenca, 16004, Spain
C.S. Cuntis
Cuntis, Pontevedra, 36678, Spain
Consultorio Guargacho
El Monte, Tenerife, 38632, Spain
CS Puerto de Santa María Sur
El Puerto de Santa María, Cádiz, 11500, Spain
CS San Miguel Basauri
Elexalde, Bizcaia, 48970, Spain
CAP Pubilla Casas
Esplugues de Llobregat, Barcelona, 8950, Spain
CS Lobillas
Estepona, Málaga, 29680, Spain
CS Favara
Favara, Valencia, 46614, Spain
CAP Figueres Ernest Lluch
Figueres, Girona, 17600, Spain
CAP Josep Masdevall
Figueres, Girona, 17600, Spain
CS Panaderas
Fuenlabrada, Madrid, 28944, Spain
CS Cuzco
Fuenlabrada, Madrid, 28945, Spain
CS Natahoyo
Gijón, 33212, Spain
CAP Montilivi
Girona, 17003, Spain
Consultorio Gorraiz
Gorráiz, 31620, Spain
CAP Hostalric
Hostalric, Girona, 17450, Spain
CS Huelva Centro
Huelva, 21001, Spain
CS Bulevar
Jaén, 23009, Spain
C.S. Jávea
Jávea, Alicante, 3730, Spain
EAP - Centre - L´Hospitalet de Llobregat
L'Hospitalet de Llobregat, Barcelona, 8901, Spain
CAP Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
CS La Almunia de Doña Godina
La Almunia de Doña Godina, Zaragoza, 50100, Spain
CS La Bañeza II
La Bañeza, León, 24750, Spain
CS La Cañada
La Cañada, Almería, 4120, Spain
CS La Carlota
La Carlota, Córdoba, 14100, Spain
CS La Línea Poniente
La Línea de La Concepción, Cádiz, 11300, Spain
CS La Roda
La Roda, Albacete, 2630, Spain
CS Zubia
La Zubia, Granada, 18140, Spain
CS Laredo
Laredo, Cantabria, 39770, Spain
CS Las Cabezas de San Juan
Las Cabezas, Sevilla, 41730, Spain
CS San José
Las Palmas, 35016, Spain
CS Maspalomas
Las Palmas, 35109, Spain
CS Eras de Renueva
León, 24008, Spain
CS Loeches
Loeches, Madrid, 28890, Spain
CS Lora del Río Virgen de Setefilla
Lora Del Río, Sevilla, 41440, Spain
CS Los Barrios
Los Barrios, Cádiz, 11370, Spain
CS Lucena
Lucena, Córdoba, 14900, Spain
CS San Roque
Lugo, 27002, Spain
CS Montesa
Madrid, 28006, Spain
CS Goya
Madrid, 28009, Spain
CS Potosí
Madrid, 28016, Spain
CS Alcalá de Guadaira
Madrid, 28018, Spain
CS Abrantes
Madrid, 28025, Spain
CS Canal de Panamá
Madrid, 28027, Spain
CS Estrecho de Corea
Madrid, 28027, Spain
CS Arroyo Media Legua
Madrid, 28030, Spain
CS Villa de Vallecas
Madrid, 28031, Spain
CS Aquitania
Madrid, 28032, Spain
CS Villaamil
Madrid, 28039, Spain
CS General Fanjul
Madrid, 28044, Spain
CS Las Aguilas
Madrid, 28044, Spain
CS Entrevias
Madrid, 28053, Spain
CS Malagon
Malagon, Ciudad Real, 13420, Spain
CS Son Rullan
Mallorca, 7009, Spain
CS Mansilla de las Mulas
Mansilla de Las Mulas, León, 24210, Spain
C.M. Mataró
Mataró, 8301, Spain
CS Huelin
Málaga, 29002, Spain
CS Victoria
Málaga, 29013, Spain
CS Meliana
Meliana, Valencia, 46133, Spain
CS Mengibar
Mengibar, Jaén, 23620, Spain
CS Moguer
Moguer Huelva, 21800, Spain
CS Montoro
Montoro, Córdoba, 14600, Spain
CS dos de Mayo
Móstoles, Madrid, 28934, Spain
CS Dr. Luengo Rodríguez
Móstoles, Madrid, 28938, Spain
CS Neda
Neda, Coruña, 15510, Spain
CS Novelda
Novelda, Alicante, 3660, Spain
CS Orgiva
Orgiva, Granada, 18400, Spain
C.S. Osuna
Osuna, Sevilla, 41640, Spain
CS Jardinillos
Palencia, 34001, Spain
CS La Puebla
Palencia, 34002, Spain
CS Pintor Oliva
Palencia, 34004, Spain
CS Palos de la Frontera
Palos de La Frontera, Huelva, 21810, Spain
C.S. Parador
Parador de Las Hortichuelas, Almería, 4720, Spain
C. S. Paterna
Paterna, Valencia, 46980, Spain
CS Pedralba
Pedralba, Valencia, 46164, Spain
Consultorio Peñíscola
Peñíscola, Castellón, 12598, Spain
CS Pilas
Pilas, Sevilla, 41840, Spain
CS Polinya de Xuquer
Polinya de Xuquer, Valencia, 46688, Spain
CS Port de Pollença
Pollença, Baleares, 7470, Spain
CS Lérez
Pontevedra, 36156, Spain
CS Repelega
Portugalete, Bizkaia, 48920, Spain
CS Castaños
Portugalete, Vizcaya, 48920, Spain
CS Puebla de Cazalla
Puebla de Cazalla, Sevilla, 41540, Spain
CS Puerto Lumbreras
Puerto Lumbreras, Murcia, 30890, Spain
CS Puertollano I
Puertollano, Ciudad Real, 13500, Spain
CS Rute
Rute, Córdoba, 14960, Spain
CS Periurbana Sur
Salamanca, 37008, Spain
CS La Cuesta
San Cristóbal La Laguna, Tenerife, 38320, Spain
CS San Fernando Dr. Cayetano Roldán
San Fernando, Cádiz, 11100, Spain
C. S. San Juan
San Juán de Alicante, 3550, Spain
CS Sancti Spiritus
Sancti Spiritus, Salamanca, 37470, Spain
CS Sangüesa
Sangüesa, Navarra, 31400, Spain
CAP Montclar
Sant Boi de Llobregat, Barcelona, 8830, Spain
CAP Dr. Vilaseca
Santa Coloma Gramanet, Barcelona, 8921, Spain
CS San Miguel de Abona
Santa Cruz de Tenerife, 38620, Spain
CS El Doctoral
Santa Lucía de Tirajana, Las Palmas, 35110, Spain
CS Santa María del Camí
Santa Mª Del Camí, Baleares, 7320, Spain
CS Perello
Sueca, Valencia, 46410, Spain
CS Sueca
Sueca, Valencia, 46410, Spain
CS Tacoronte
Tacoronte, Tenerife, 38350, Spain
CS Titaguas
Titaguas, Valencia, 46178, Spain
CS Torredelcampo
Torre Del Campo, Jaén, 23640, Spain
CS Brújula
Torrejón de Ardoz Madrid, 28850, Spain
CS Covadonga
Torrelavega, Cantabria, 39300, Spain
CS Carihuela
Torremolinos, 29620, Spain
CS Tudela Este
Tudela, Navarra, 31500, Spain
CS Valdefuentes
Valdefuentes, Cáceres, 10180, Spain
CS Ingeniero Joaquim Benlloch
Valencia, 46006, Spain
C.S. Malvarrosa
Valencia, 46011, Spain
CS Barrio de la Luz
Valencia, 46014, Spain
CS Campanar
Valencia, 46015, Spain
CS Vélez Norte
Vélez-Málaga, 29700, Spain
CS La Doblada
Vigo, 36205, Spain
C.S. Coia Vigo
Vigo, 36209, Spain
C. S. Almassera de Tonda, Vila Joiosa
Vila Joiosa, Alicante, 3570, Spain
CAP María Bernades
Viladecans, Barcelona, 8840, Spain
C. S. Xunqueira de Ambia
Xunqueira de Ambia, Ourense, 32670, Spain
CS Seminario
Zagaroza, 50009, Spain
CS Virgen de la Concha
Zamora, 49022, Spain
CS Fuentes Norte
Zaragoza, 50002, Spain
CS Canal Imperial Venecia
Zaragoza, 50006, Spain
CS Casablanca
Zaragoza, 50009, Spain
CS Seminario
Zaragoza, 50009, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Mireia Canals, (+34) 93 404 58 77
mireia.canals@boehringer-ingelheim.com
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2018
First Posted
August 2, 2018
Study Start
August 14, 2018
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
April 8, 2021
Results First Posted
February 17, 2021
Record last verified: 2021-03