OTIVACTO Spain Non Interventional Study

NCT02927795 | Completed Results

• 1 other identifier: 1237.58
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 79

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)

  Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome "physical functioning" is a subdomain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little" or "no, not limited at all", with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "no, not limited at all"). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.

  After approximately 6 weeks (visit 2)

Secondary Outcomes (5)

• The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2

  Baseline (visit 1) and after approx. week 6 (visit 2)

• Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2

  Baseline (visit 1) and after approx.week 6 (visit 2)

• Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2

  After approx. 6 weeks (visit 2) of treatment initiation

• Patient Satisfaction With Inhaling From the Respimat® Device

  After approx. 6 weeks (visit 2) of treatment initiation

• Patient Satisfaction With Handling of the Respimat® Inhalation Device

  After approx. 6 weeks (visit 2) of treatment initiation

Study Arms (1)

Spiolto Respimat

QOL measurement of COPD patients taking Spiolto Respimat

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients

You may qualify if:

• Written informed consent prior to participation
• Female and male patients = or \> 40 years of age
• 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

You may not qualify if:

• Patients with contraindications according to Spiolto® Respimat® SmPC
• Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
• 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
• Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
• Pregnancy and lactation
• Patients currently listed for lung transplantation
• Current participation in any clinical trial or any other non-interventional study of a drug or device

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (79)

Centro de Salud Águilas Sur

Aguilas (Murcia), 30880, Spain

Location

Consultorio Médico de Albelda

Albelda (Huesca), 22558, Spain

Location

Centro de Salud Alcantarilla-Sangonera

Alcantarilla (Murcia), 30820, Spain

Location

Centro de Salud Alquerías Raal

Alquerías (Murcia), 30580, Spain

Location

Centro de Salud Aranda Norte

Aranda de Duero (Burgos), 09400, Spain

Location

Centro de Salud Ávila Estación

Ávila, 05001, Spain

Location

Centro de Salud Ávila Rural

Ávila, 05003, Spain

Location

Centro de Salud Ávila Sureste

Ávila, 05003, Spain

Location

Centro de Salud Ávila Suroeste

Ávila, 05003, Spain

Location

Centro de Salud La Paz-Cruces

Barakaldo (Vizcaya), 48903, Spain

Location

Consulta Privada

Barcelona, 8022, Spain

Location

Centro de Salud de Beniel

Beniel (Murcia), 30130, Spain

Location

Zorroza Centro de Salud

Bilbao (Vizcaya), 48002, Spain

Location

Centro de Salud Gazteleku

Bilbao (Vizcaya), 48007, Spain

Location

Centro Médico IMQ

Bilbao (Vizcaya), 48011, Spain

Location

Consulta Privada

Bizcaia, 20600, Spain

Location

Centro de Salud Bullas

Bullas (Murcia), 30180, Spain

Location

Centro de Salud San Agustín

Burgos, 09001, Spain

Location

Centro de Salud Burgos Rural Norte

Burgos, 09006, Spain

Location

Centro de Salud Comuneros

Burgos, 09006, Spain

Location

Centro de Salud Las Torres

Burgos, 09006, Spain

Location

Centre d'Atenció Primària Calella

Calella (Barcelona), 08370, Spain

Location

Centro de Salud Cartagena Este

Cartagena (Murcia), 30203, Spain

Location

Centro de Salud Cartagena Oeste

Cartagena (Murcia), 30205, Spain

Location

Centro de Salud del Barrio de Peral

Cartagena (Murcia), 30300, Spain

Location

Centre d'Atenció Primària Centelles

Centelles (Barcelona), 08540, Spain

Location

Centro de Salud de Torrekua

Eibar (Guipúzcoa), 20600, Spain

Location

Centro de Salud Elgoibar

Elgoibar (Guipuzkoa), 20870, Spain

Location

Centro de Salud Fuente Álamo

Fuente Álamo (Murcia), 30320, Spain

Location

C.S. Guardo

Guardo (Palencia), 34880, Spain

Location

Centro de Salud Sodupe

Güeñes (Vizcaya), 48830, Spain

Location

Centro de Salud La Unión

La Unión (Murcia), 30360, Spain

Location

Centro de Salud de Librilla

Librilla (Murcia), 30892, Spain

Location

Centre d'Atenció Primària Lloret de Mar

Lloret de Mar (Girona), 17310, Spain

Location

Centro de Salud Joaquín Elizalde

Logroño, 26004, Spain

Location

Centro de Salud Lorca Sur San José

Lorca (Murcia), 30800, Spain

Location

Centro de Salud San Andrés

Madrid, 28021, Spain

Location

Centre Mèdic Bages

Manresa, 08243, Spain

Location

CS Medina del Campo

Medina del Campo, 47400, Spain

Location

Centro de Salud Medina del Campo Urbano

Medina Del Campo (Valladolid), 47400, Spain

Location

Centro de Salud Miranda Oeste

Miranda de Ebro (Burgos), 09200, Spain

Location

Centro de Salud Mula (Consultorio Albudeite)

Mula (Murcia), 30170, Spain

Location

Consultorio Casillas

Murcia, 30007, Spain

Location

Centro de Salud Murcia Sur

Murcia, 30010, Spain

Location

Centro de Salud Murcia-Infante Juan Manuel

Murcia, 30011, Spain

Location

Centro de Salud Espinardo

Murcia, 30100, Spain

Location

Consultorio de Cobatillas

Murcia, 30163, Spain

Location

Centro de Salud Nájera

Nájera (La Rioja), 26300, Spain

Location

Centro de Salud Oion

Oion (Álava), 01320, Spain

Location

Consultorio Médico Palazuelos

Palazuelos de Eresma (Segovia), 40194, Spain

Location

Centro de Salud Pintor Oliva

Palencia, 34004, Spain

Location

Centro Salud Peñaranda de Bracamonte

Peñaranda de Bracamonte (Salamanca), 37300, Spain

Location

Centro de Salud Castaños

Portugalete (Vizcaya), 48920, Spain

Location

Pozo Estrecho Centro de Salud

Pozo Estrecho (Murcia), 30594, Spain

Location

Centro de Salud Quintanar de la Sierra

Quintanar de La Sierra (Burgos), 09670, Spain

Location

Centro de Salud Universidad Centro de Salamanca

Salamanca, 37001, Spain

Location

Centro de Salud Garrido Sur

Salamanca, 37003, Spain

Location

San Bernado Oeste_Centro de Salud Miguel Armijo

Salamanca, 37007, Spain

Location

Centro de Salud Salvatierra

Salvatierra (Álava), 1200, Spain

Location

Centro de Salud de Amara Centro

San Sebastián (Guipúzcoa), 20006, Spain

Location

Centro de Saud Amara-Berri 20010

San Sebastián (Guipúzcoa), 20010, Spain

Location

Residencia Geriátrica Aldakonea

San Sebastián (Guipúzcoa), 20012, Spain

Location

Centro de Salud Ambulatorio Gros

San Sebastián (Guipúzcoa), 20013, Spain

Location

Centro de Salud Santomera

Santomera (Murcia), 30140, Spain

Location

Centro de Salud Segovia I

Segovia, 40002, Spain

Location

Clínica Médica Goya

Segovia, 40002, Spain

Location

Centro de Salud Segovia II_ La Albuera

Segovia, 40004, Spain

Location

Centro de Salud Markonzaga

Sestao (Vizcaya), 48910, Spain

Location

Centro de Salud Torre Pacheco

Torre Pacheco (Murcia), 30700, Spain

Location

Centro de Salud Tudela de Duero

Tudela de Duero (Valladolid), 47320, Spain

Location

Circunvalación Centro de Salud

Valladolid, 47012, Spain

Location

Centro de Salud Canterac

Valladolid, 47013, Spain

Location

Centro de Salud Casco Viejo

Vitoria (Álava), 01001, Spain

Location

Centro Médico Medicentro

Vitoria (Álava), 01001, Spain

Location

C.S. Aranbizkarra I

Vitoria (Álava), 01002, Spain

Location

Policlínica San José

Vitoria (Álava), 01008, Spain

Location

Centro de Salud Yecla Oeste

Yecla (Murcia), 30510, Spain

Location

Centro de Salud Santa Elena

Zamora, 49007, Spain

Location

Centro de Salud Puerta Nueva

Zamora, 49016, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The interpretation of the results is limited by the lower number of patients recruited compared to what was planned. Results may not be representative of the Spanish COPD population.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

• Mireia Canals, +34607550925

  mireia.canals@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: April 26, 2017
• Primary Completion: September 18, 2018
• Study Completion: September 18, 2018
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

ES (79)