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Pulmonary Disease, Chronic ObstructiveNCT02927795

OTIVACTO Spain Non Interventional Study

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 79 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
How many people
257 participants
Where
79 sitesSpain
Study dates
26 Apr 2017to 18 Sep 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COPD patients

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

Spain79 sites

  • Centro de Salud Águilas Sur

    Aguilas (Murcia), 30880

  • Consultorio Médico de Albelda

    Albelda (Huesca), 22558

  • Centro de Salud Alcantarilla-Sangonera

    Alcantarilla (Murcia), 30820

  • Centro de Salud Alquerías Raal

    Alquerías (Murcia), 30580

  • Centro de Salud Aranda Norte

    Aranda de Duero (Burgos), 09400

  • Centro de Salud Ávila Estación

    Ávila, 05001

  • Centro de Salud Ávila Rural

    Ávila, 05003

  • Centro de Salud Ávila Sureste

    Ávila, 05003

  • Centro de Salud Ávila Suroeste

    Ávila, 05003

  • Centro de Salud La Paz-Cruces

    Barakaldo (Vizcaya), 48903

  • Consulta Privada

    Barcelona, 8022

  • Centro de Salud de Beniel

    Beniel (Murcia), 30130

  • Zorroza Centro de Salud

    Bilbao (Vizcaya), 48002

  • Centro de Salud Gazteleku

    Bilbao (Vizcaya), 48007

  • Centro Médico IMQ

    Bilbao (Vizcaya), 48011

  • Consulta Privada

    Bizcaia, 20600

  • Centro de Salud Bullas

    Bullas (Murcia), 30180

  • Centro de Salud San Agustín

    Burgos, 09001

  • Centro de Salud Burgos Rural Norte

    Burgos, 09006

  • Centro de Salud Comuneros

    Burgos, 09006

  • Centro de Salud Las Torres

    Burgos, 09006

  • Centre d'Atenció Primària Calella

    Calella (Barcelona), 08370

  • Centro de Salud Cartagena Este

    Cartagena (Murcia), 30203

  • Centro de Salud Cartagena Oeste

    Cartagena (Murcia), 30205

  • Centro de Salud del Barrio de Peral

    Cartagena (Murcia), 30300

  • Centre d'Atenció Primària Centelles

    Centelles (Barcelona), 08540

  • Centro de Salud de Torrekua

    Eibar (Guipúzcoa), 20600

  • Centro de Salud Elgoibar

    Elgoibar (Guipuzkoa), 20870

  • Centro de Salud Fuente Álamo

    Fuente Álamo (Murcia), 30320

  • C.S. Guardo

    Guardo (Palencia), 34880

  • Centro de Salud Sodupe

    Güeñes (Vizcaya), 48830

  • Centro de Salud La Unión

    La Unión (Murcia), 30360

  • Centro de Salud de Librilla

    Librilla (Murcia), 30892

  • Centre d'Atenció Primària Lloret de Mar

    Lloret de Mar (Girona), 17310

  • Centro de Salud Joaquín Elizalde

    Logroño, 26004

  • Centro de Salud Lorca Sur San José

    Lorca (Murcia), 30800

  • Centro de Salud San Andrés

    Madrid, 28021

  • Centre Mèdic Bages

    Manresa, 08243

  • CS Medina del Campo

    Medina del Campo, 47400

  • Centro de Salud Medina del Campo Urbano

    Medina Del Campo (Valladolid), 47400

  • Centro de Salud Miranda Oeste

    Miranda de Ebro (Burgos), 09200

  • Centro de Salud Mula (Consultorio Albudeite)

    Mula (Murcia), 30170

  • Consultorio Casillas

    Murcia, 30007

  • Centro de Salud Murcia Sur

    Murcia, 30010

  • Centro de Salud Murcia-Infante Juan Manuel

    Murcia, 30011

  • Centro de Salud Espinardo

    Murcia, 30100

  • Consultorio de Cobatillas

    Murcia, 30163

  • Centro de Salud Nájera

    Nájera (La Rioja), 26300

  • Centro de Salud Oion

    Oion (Álava), 01320

  • Consultorio Médico Palazuelos

    Palazuelos de Eresma (Segovia), 40194

  • Centro de Salud Pintor Oliva

    Palencia, 34004

  • Centro Salud Peñaranda de Bracamonte

    Peñaranda de Bracamonte (Salamanca), 37300

  • Centro de Salud Castaños

    Portugalete (Vizcaya), 48920

  • Pozo Estrecho Centro de Salud

    Pozo Estrecho (Murcia), 30594

  • Centro de Salud Quintanar de la Sierra

    Quintanar de La Sierra (Burgos), 09670

  • Centro de Salud Universidad Centro de Salamanca

    Salamanca, 37001

  • Centro de Salud Garrido Sur

    Salamanca, 37003

  • San Bernado Oeste_Centro de Salud Miguel Armijo

    Salamanca, 37007

  • Centro de Salud Salvatierra

    Salvatierra (Álava), 1200

  • Centro de Salud de Amara Centro

    San Sebastián (Guipúzcoa), 20006

  • Centro de Saud Amara-Berri 20010

    San Sebastián (Guipúzcoa), 20010

  • Residencia Geriátrica Aldakonea

    San Sebastián (Guipúzcoa), 20012

  • Centro de Salud Ambulatorio Gros

    San Sebastián (Guipúzcoa), 20013

  • Centro de Salud Santomera

    Santomera (Murcia), 30140

  • Centro de Salud Segovia I

    Segovia, 40002

  • Clínica Médica Goya

    Segovia, 40002

  • Centro de Salud Segovia II_ La Albuera

    Segovia, 40004

  • Centro de Salud Markonzaga

    Sestao (Vizcaya), 48910

  • Centro de Salud Torre Pacheco

    Torre Pacheco (Murcia), 30700

  • Centro de Salud Tudela de Duero

    Tudela de Duero (Valladolid), 47320

  • Circunvalación Centro de Salud

    Valladolid, 47012

  • Centro de Salud Canterac

    Valladolid, 47013

  • Centro de Salud Casco Viejo

    Vitoria (Álava), 01001

  • Centro Médico Medicentro

    Vitoria (Álava), 01001

  • C.S. Aranbizkarra I

    Vitoria (Álava), 01002

  • Policlínica San José

    Vitoria (Álava), 01008

  • Centro de Salud Yecla Oeste

    Yecla (Murcia), 30510

  • Centro de Salud Santa Elena

    Zamora, 49007

  • Centro de Salud Puerta Nueva

    Zamora, 49016

Other trials in Spain

About this 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

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.

Read the detailed description

Purpose:

Study Design:

Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02927795
Study groupRoleWhat they receive
Spiolto RespimatQOL measurement of COPD patients taking Spiolto Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After approximately 6 weeks (visit 2)

Secondary outcomes (5)

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

    The change in Physical functioning questionnaire (PF-10 ) score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the mean for change from baseline values across all patients was calculated.

    The PF-10 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.

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

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

    The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent

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

  3. Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2

    A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

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

  4. Patient Satisfaction With Inhaling From the Respimat® Device

    A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

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

  5. Patient Satisfaction With Handling of the Respimat® Inhalation Device

    A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2016 (estimated)
  2. Study start26 Apr 2017
  3. Primary completion18 Sep 2018
  4. Study completion18 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927795
Sponsor's protocol ID
1237.58
Status last verified
Sep 2019
First submitted
6 Oct 2016
Last updated
30 Sep 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 79 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) (time frame: After approximately 6 weeks (visit 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.

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OTIVACTO Spain Non Interventional Study (NCT02927795) | AzTrials