Clinical trial NCT02927795: OTIVACTO Spain Non Interventional Study
Official title: Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 257
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: 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.

Detailed description: Purpose:

Study Design:

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
timeFrame: After approximately 6 weeks (visit 2)
Secondary outcomes:
measure: The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
timeFrame: Baseline (visit 1) and after approx. week 6 (visit 2)
measure: Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2
timeFrame: Baseline (visit 1) and after approx.week 6 (visit 2)
measure: Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2
timeFrame: After approx. 6 weeks (visit 2) of treatment initiation
measure: Patient Satisfaction With Inhaling From the Respimat® Device
timeFrame: After approx. 6 weeks (visit 2) of treatment initiation
measure: Patient Satisfaction With Handling of the Respimat® Inhalation Device
timeFrame: After approx. 6 weeks (visit 2) of treatment initiation
Other outcomes:
Locations:
city: Aguilas (Murcia)
country: Spain
facility: Centro de Salud Águilas Sur
city: Albelda (Huesca)
country: Spain
facility: Consultorio Médico de Albelda
city: Alcantarilla (Murcia)
country: Spain
facility: Centro de Salud Alcantarilla-Sangonera
city: Alquerías (Murcia)
country: Spain
facility: Centro de Salud Alquerías Raal
city: Aranda De Duero (Burgos)
country: Spain
facility: Centro de Salud Aranda Norte
city: Barakaldo (Vizcaya)
country: Spain
facility: Centro de Salud La Paz-Cruces
city: Barcelona
country: Spain
facility: Consulta Privada
city: Beniel (Murcia)
country: Spain
facility: Centro de Salud de Beniel
city: Bilbao (Vizcaya)
country: Spain
facility: Zorroza Centro de Salud
city: Bilbao (Vizcaya)
country: Spain
facility: Centro de Salud Gazteleku
city: Bilbao (Vizcaya)
country: Spain
facility: Centro Médico IMQ
city: Bizcaia
country: Spain
facility: Consulta Privada
city: Bullas (Murcia)
country: Spain
facility: Centro de Salud Bullas
city: Burgos
country: Spain
facility: Centro de Salud San Agustín
city: Burgos
country: Spain
facility: Centro de Salud Burgos Rural Norte
city: Burgos
country: Spain
facility: Centro de Salud Comuneros
city: Burgos
country: Spain
facility: Centro de Salud Las Torres
city: Calella (Barcelona)
country: Spain
facility: Centre d'Atenció Primària Calella
city: Cartagena (Murcia)
country: Spain
facility: Centro de Salud Cartagena Este
city: Cartagena (Murcia)
country: Spain
facility: Centro de Salud Cartagena Oeste
city: Cartagena (Murcia)
country: Spain
facility: Centro de Salud del Barrio de Peral
city: Centelles (Barcelona)
country: Spain
facility: Centre d'Atenció Primària Centelles
city: Eibar (Guipúzcoa)
country: Spain
facility: Centro de Salud de Torrekua
city: Elgoibar (Guipuzkoa)
country: Spain
facility: Centro de Salud Elgoibar
city: Fuente Álamo (Murcia)
country: Spain
facility: Centro de Salud Fuente Álamo
city: Guardo (Palencia)
country: Spain
facility: C.S. Guardo
city: Güeñes (Vizcaya)
country: Spain
facility: Centro de Salud Sodupe
city: La Unión (Murcia)
country: Spain
facility: Centro de Salud La Unión
city: Librilla (Murcia)
country: Spain
facility: Centro de Salud de Librilla
city: Lloret De Mar (Girona)
country: Spain
facility: Centre d'Atenció Primària Lloret de Mar
city: Logroño
country: Spain
facility: Centro de Salud Joaquín Elizalde
city: Lorca (Murcia)
country: Spain
facility: Centro de Salud Lorca Sur San José
city: Madrid
country: Spain
facility: Centro de Salud San Andrés
city: Manresa
country: Spain
facility: Centre Mèdic Bages
city: Medina Del Campo (Valladolid)
country: Spain
facility: Centro de Salud Medina del Campo Urbano
city: Medina del Campo
country: Spain
facility: CS Medina del Campo
city: Miranda De Ebro (Burgos)
country: Spain
facility: Centro de Salud Miranda Oeste
city: Mula (Murcia)
country: Spain
facility: Centro de Salud Mula (Consultorio Albudeite)
city: Murcia
country: Spain
facility: Consultorio Casillas
city: Murcia
country: Spain
facility: Centro de Salud Murcia Sur
city: Murcia
country: Spain
facility: Centro de Salud Murcia-Infante Juan Manuel
city: Murcia
country: Spain
facility: Centro de Salud Espinardo
city: Murcia
country: Spain
facility: Consultorio de Cobatillas
city: Nájera (La Rioja)
country: Spain
facility: Centro de Salud Nájera
city: Oion (Álava)
country: Spain
facility: Centro de Salud Oion
city: Palazuelos De Eresma (Segovia)
country: Spain
facility: Consultorio Médico Palazuelos
city: Palencia
country: Spain
facility: Centro de Salud Pintor Oliva
city: Peñaranda De Bracamonte (Salamanca)
country: Spain
facility: Centro Salud Peñaranda de Bracamonte
city: Portugalete (Vizcaya)
country: Spain
facility: Centro de Salud Castaños
city: Pozo Estrecho (Murcia)
country: Spain
facility: Pozo Estrecho Centro de Salud
city: Quintanar De La Sierra (Burgos)
country: Spain
facility: Centro de Salud Quintanar de la Sierra
city: Salamanca
country: Spain
facility: Centro de Salud Universidad Centro de Salamanca
city: Salamanca
country: Spain
facility: Centro de Salud Garrido Sur
city: Salamanca
country: Spain
facility: San Bernado Oeste_Centro de Salud Miguel Armijo
city: Salvatierra (Álava)
country: Spain
facility: Centro de Salud Salvatierra
city: San Sebastián (Guipúzcoa)
country: Spain
facility: Centro de Salud de Amara Centro
city: San Sebastián (Guipúzcoa)
country: Spain
facility: Centro de Saud Amara-Berri 20010
city: San Sebastián (Guipúzcoa)
country: Spain
facility: Residencia Geriátrica Aldakonea
city: San Sebastián (Guipúzcoa)
country: Spain
facility: Centro de Salud Ambulatorio Gros
city: Santomera (Murcia)
country: Spain
facility: Centro de Salud Santomera
city: Segovia
country: Spain
facility: Centro de Salud Segovia I
city: Segovia
country: Spain
facility: Clínica Médica Goya
city: Segovia
country: Spain
facility: Centro de Salud Segovia II_ La Albuera
city: Sestao (Vizcaya)
country: Spain
facility: Centro de Salud Markonzaga
city: Torre Pacheco (Murcia)
country: Spain
facility: Centro de Salud Torre Pacheco
city: Tudela De Duero (Valladolid)
country: Spain
facility: Centro de Salud Tudela de Duero
city: Valladolid
country: Spain
facility: Circunvalación Centro de Salud
city: Valladolid
country: Spain
facility: Centro de Salud Canterac
city: Vitoria (Álava)
country: Spain
facility: Centro de Salud Casco Viejo
city: Vitoria (Álava)
country: Spain
facility: Centro Médico Medicentro
city: Vitoria (Álava)
country: Spain
facility: C.S. Aranbizkarra I
city: Vitoria (Álava)
country: Spain
facility: Policlínica San José
city: Yecla (Murcia)
country: Spain
facility: Centro de Salud Yecla Oeste
city: Zamora
country: Spain
facility: Centro de Salud Santa Elena
city: Zamora
country: Spain
facility: Centro de Salud Puerta Nueva
city: Ávila
country: Spain
facility: Centro de Salud Ávila Estación
city: Ávila
country: Spain
facility: Centro de Salud Ávila Rural
city: Ávila
country: Spain
facility: Centro de Salud Ávila Sureste
city: Ávila
country: Spain
facility: Centro de Salud Ávila Suroeste
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia Canals, +34607550925
role: STUDY_CHAIR
References: