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OTIVACTO Spain Non Interventional Study

NCT ID: NCT02927795

Last Updated: 2019-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-26

Study Completion Date

2018-09-18

Brief Summary

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This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

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Detailed Description

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Purpose:

Study Design:

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Spiolto Respimat

QOL measurement of COPD patients taking Spiolto Respimat

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent prior to participation
2. Female and male patients = or \> 40 years of age
3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation

Exclusion Criteria

1. Patients with contraindications according to Spiolto® Respimat® SmPC
2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
3. Patients continuing Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Mireia Canals, +34607550925

Role: STUDY_CHAIR

[email protected]

Locations

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Centro de Salud Águilas Sur

Aguilas (Murcia), , Spain

Site Status

Consultorio Médico de Albelda

Albelda (Huesca), , Spain

Site Status

Centro de Salud Alcantarilla-Sangonera

Alcantarilla (Murcia), , Spain

Site Status

Centro de Salud Alquerías Raal

Alquerías (Murcia), , Spain

Site Status

Centro de Salud Aranda Norte

Aranda de Duero (Burgos), , Spain

Site Status

Centro de Salud Ávila Estación

Ávila, , Spain

Site Status

Centro de Salud Ávila Rural

Ávila, , Spain

Site Status

Centro de Salud Ávila Sureste

Ávila, , Spain

Site Status

Centro de Salud Ávila Suroeste

Ávila, , Spain

Site Status

Centro de Salud La Paz-Cruces

Barakaldo (Vizcaya), , Spain

Site Status

Consulta Privada

Barcelona, , Spain

Site Status

Centro de Salud de Beniel

Beniel (Murcia), , Spain

Site Status

Zorroza Centro de Salud

Bilbao (Vizcaya), , Spain

Site Status

Centro de Salud Gazteleku

Bilbao (Vizcaya), , Spain

Site Status

Centro Médico IMQ

Bilbao (Vizcaya), , Spain

Site Status

Consulta Privada

Bizcaia, , Spain

Site Status

Centro de Salud Bullas

Bullas (Murcia), , Spain

Site Status

Centro de Salud San Agustín

Burgos, , Spain

Site Status

Centro de Salud Burgos Rural Norte

Burgos, , Spain

Site Status

Centro de Salud Comuneros

Burgos, , Spain

Site Status

Centro de Salud Las Torres

Burgos, , Spain

Site Status

Centre d'Atenció Primària Calella

Calella (Barcelona), , Spain

Site Status

Centro de Salud Cartagena Este

Cartagena (Murcia), , Spain

Site Status

Centro de Salud Cartagena Oeste

Cartagena (Murcia), , Spain

Site Status

Centro de Salud del Barrio de Peral

Cartagena (Murcia), , Spain

Site Status

Centre d'Atenció Primària Centelles

Centelles (Barcelona), , Spain

Site Status

Centro de Salud de Torrekua

Eibar (Guipúzcoa), , Spain

Site Status

Centro de Salud Elgoibar

Elgoibar (Guipuzkoa), , Spain

Site Status

Centro de Salud Fuente Álamo

Fuente Álamo (Murcia), , Spain

Site Status

C.S. Guardo

Guardo (Palencia), , Spain

Site Status

Centro de Salud Sodupe

Güeñes (Vizcaya), , Spain

Site Status

Centro de Salud La Unión

La Unión (Murcia), , Spain

Site Status

Centro de Salud de Librilla

Librilla (Murcia), , Spain

Site Status

Centre d'Atenció Primària Lloret de Mar

Lloret de Mar (Girona), , Spain

Site Status

Centro de Salud Joaquín Elizalde

Logroño, , Spain

Site Status

Centro de Salud Lorca Sur San José

Lorca (Murcia), , Spain

Site Status

Centro de Salud San Andrés

Madrid, , Spain

Site Status

Centre Mèdic Bages

Manresa, , Spain

Site Status

CS Medina del Campo

Medina del Campo, , Spain

Site Status

Centro de Salud Medina del Campo Urbano

Medina Del Campo (Valladolid), , Spain

Site Status

Centro de Salud Miranda Oeste

Miranda de Ebro (Burgos), , Spain

Site Status

Centro de Salud Mula (Consultorio Albudeite)

Mula (Murcia), , Spain

Site Status

Consultorio Casillas

Murcia, , Spain

Site Status

Centro de Salud Murcia Sur

Murcia, , Spain

Site Status

Centro de Salud Murcia-Infante Juan Manuel

Murcia, , Spain

Site Status

Centro de Salud Espinardo

Murcia, , Spain

Site Status

Consultorio de Cobatillas

Murcia, , Spain

Site Status

Centro de Salud Nájera

Nájera (La Rioja), , Spain

Site Status

Centro de Salud Oion

Oion (Álava), , Spain

Site Status

Consultorio Médico Palazuelos

Palazuelos de Eresma (Segovia), , Spain

Site Status

Centro de Salud Pintor Oliva

Palencia, , Spain

Site Status

Centro Salud Peñaranda de Bracamonte

Peñaranda de Bracamonte (Salamanca), , Spain

Site Status

Centro de Salud Castaños

Portugalete (Vizcaya), , Spain

Site Status

Pozo Estrecho Centro de Salud

Pozo Estrecho (Murcia), , Spain

Site Status

Centro de Salud Quintanar de la Sierra

Quintanar de La Sierra (Burgos), , Spain

Site Status

Centro de Salud Universidad Centro de Salamanca

Salamanca, , Spain

Site Status

Centro de Salud Garrido Sur

Salamanca, , Spain

Site Status

San Bernado Oeste_Centro de Salud Miguel Armijo

Salamanca, , Spain

Site Status

Centro de Salud Salvatierra

Salvatierra (Álava), , Spain

Site Status

Centro de Salud de Amara Centro

San Sebastián (Guipúzcoa), , Spain

Site Status

Centro de Saud Amara-Berri 20010

San Sebastián (Guipúzcoa), , Spain

Site Status

Residencia Geriátrica Aldakonea

San Sebastián (Guipúzcoa), , Spain

Site Status

Centro de Salud Ambulatorio Gros

San Sebastián (Guipúzcoa), , Spain

Site Status

Centro de Salud Santomera

Santomera (Murcia), , Spain

Site Status

Centro de Salud Segovia I

Segovia, , Spain

Site Status

Clínica Médica Goya

Segovia, , Spain

Site Status

Centro de Salud Segovia II_ La Albuera

Segovia, , Spain

Site Status

Centro de Salud Markonzaga

Sestao (Vizcaya), , Spain

Site Status

Centro de Salud Torre Pacheco

Torre Pacheco (Murcia), , Spain

Site Status

Centro de Salud Tudela de Duero

Tudela de Duero (Valladolid), , Spain

Site Status

Circunvalación Centro de Salud

Valladolid, , Spain

Site Status

Centro de Salud Canterac

Valladolid, , Spain

Site Status

Centro de Salud Casco Viejo

Vitoria (Álava), , Spain

Site Status

Centro Médico Medicentro

Vitoria (Álava), , Spain

Site Status

C.S. Aranbizkarra I

Vitoria (Álava), , Spain

Site Status

Policlínica San José

Vitoria (Álava), , Spain

Site Status

Centro de Salud Yecla Oeste

Yecla (Murcia), , Spain

Site Status

Centro de Salud Santa Elena

Zamora, , Spain

Site Status

Centro de Salud Puerta Nueva

Zamora, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1237.58

Identifier Type: -

Identifier Source: org_study_id

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