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Pulmonary Disease, Chronic ObstructiveNCT03165045

Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 108 sites in Germany.

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

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Spiolto® Respimat®
How many people
1,351 participants
Where
108 sitesGermany
Study dates
26 May 2017to 24 Mar 2019
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: approximately 1300 patients from approximately 400 sites in Germany will be collected. Site selection will be performed to reflect routine COPD care in Germany in order to secure representativeness of the COPD population.

Who may be able to join

  • Patients can be included if all of the following criteria are met:
  • Written informed consent prior to participation
  • Female and male patients ≥40 years of age
  • Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
  • Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.

Who cannot join

  • Patients with contraindications according to Spiolto® Respimat® SmPC
  • Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
  • Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
  • Pregnancy and lactation
  • Current participation in any clinical trial or any other non-interventional study of a drug or device.

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

Germany108 sites

  • Dr. Weghmann

    Aachen, 52066

  • Praxis Edgar Schaubert

    Aldenhoven, 52457

  • MZM Medizin Zentr. Marienstrasse

    Aldenhoven B Jülich, 52457

  • Praxis Dr. Selbig

    Ansbach, 91522

  • Dr. Ludwig

    Bad Bentheim, 48455

  • Dr. Jung

    Bad Ditzenbach, 73342

  • Praxis Dr. med. Graubner

    Bad Sachsa, 37441

  • Dr. Callitsis

    Bad Vilbel, 61118

  • Dr. Junggeburth

    Bad Wörishofen, 86825

  • Praxis Edgar Hossbach

    Berkatal-Frankershausen, 37297

  • Dr. Urban

    Berlin, 10711

  • Praxis Abdullah Sahan

    Berlin, 12049

  • Dr. Kopf

    Berlin, 12459

  • Dr. Thalhofer

    Berlin, 14163

  • Gemeinschaftspraxis Dres. Wetterau/Dimar

    Biberach, 88400

  • Dr. Kassik

    Bitterfeld-Wolfen, 06749

  • Dr. Biedermann

    Blankenhain , Thür, 99444

  • Praxis Dr. Andreas Schwittay

    Böhlen, 04564

  • Gemeinschaftspraxis Dres. Bartels

    Breuberg, 64747

  • Praxis B. Metzlaff

    Büchen, 21514

  • Dres. Ottlewski/Sutor

    Burgwedel, 30938

  • Praxis A. Hermann/L. Hermann

    Cloppenburg, 49661

  • Praxis Dr. Käßner

    Cottbus, 03050

  • Dres. Forster/Kneser/Steinmetz

    Darmstadt, 64283

  • Dres. Jung/Jung

    Deggingen, 73326

  • Dr. Franz

    Dietzenbach, 63128

  • Dres. Tietjens/Tobias

    Dortmund, 44135

  • Dr. Schwiese

    Duisburg, 47051

  • Dr. Kontny

    Duisburg, 47055

  • Dres. Berger/Schäfer/Winkels

    Düren, 52349

  • Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise

    Düsseldorf, 40217

  • Ges. f. Med. Fortbildung

    Düsseldorf, 40547

  • Praxis Dr. Andreas Kroll

    Einbeck, 37574

  • Dr. Schmidt

    Erfurt, 99084

  • Dres. Brüning/Schax

    Essen, 45134

  • Praxis Dr. Schmorell

    Forchheim, 91301

  • Dres. Engelhard/Wihl

    Frankenberg, 35066

  • Studienzentrum Dr. Klaus Keller

    Frankfurt, 60389

  • Dr. Morgner

    Freiberg, 09599

  • Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer

    Friedrichsthal, 66299

  • Dr. Xanthopoulos

    Fürstenwalde, 15517

  • Praxis A. Heinze

    Fürstenwalde, 15517

  • Dr. Sommer

    Garmisch-Partenkirchen, 82467

  • Praxis C. Staack/Z. Zadrozny

    Gelsenkirchen, 45891

  • Praxis Dr. Körössy

    Geretsried, 82538

  • Das HausarztZentrum

    Grafenrheinfeld, 97506

  • Dres. Koenen & Partner

    Grafenrheinfeld, 97506

  • Praxis Dr. med. Werner Gams

    Gütersloh, 33330

  • Dr. Waida

    Haan, 42781

  • Pneumologicum Halle

    Halle, 06108

  • Praxis J. Lemke

    Halle, 06110

  • Dr. Polke

    Hamburg, 20357

  • Praxis Dr. Kaase

    Hamburg, 22529

  • Dr. Abenhardt

    Heidelberg, 69115

  • Praxis J. Hinrichs-Pavlik

    Heidelberg , Neckar, 69115

  • Praxis Dr. Constance Koch

    Heilbad Heiligenstadt, 37308

  • Praxis J. Korsakas

    Heudeber, 38855

  • Praxis Dres. Berg & Partner

    Höchstadt an der Aisch, 91315

  • Dr. Schulze

    Jerichow, 39319

  • Ambulantes Zentrum

    Kalawa, 03205

  • Dr. Schmitz

    Kall, 53925

  • Praxis Dr. Bernhard Beckmann

    Kamen, 59174

  • Praxis G. Mohanty

    Kamp-Lintfort, 47475

  • Praxis Dr. Dietrich Auge

    Koblenz, 56068

  • Dres. Lehmann/Schwerdtfeger

    Köthen, 06366

  • Praxis Dr. Astrid Pfitzer

    Kronach, 96317

  • KMG Klinikum Mitte GmbH

    Kyritz , Prignitz, 16866

  • Praxis Dr. Weberling

    Lahnau, 35633

  • POIS Leipzig GbR

    Leipzig, 04357

  • Dres. Bonitz/Hoheisel

    Leipzig, 4275

  • Dr. Seiz

    Leonberg , Württ, 71229

  • Praxis Dr. Hannelore Pitule

    Ludwigshafen am Rhein, 67061

  • Dres. Kock & Partner

    Mainaschaff, 63814

  • Dr. Saur

    Mannheim, 68161

  • Praxis Dr. Hermann A. Trauth

    Marburg, 35037

  • Gemeinschaftspraxis Dres. Jansen/Nolzen

    Menden, 58706

  • Dr. Bartsch

    Moers, 47441

  • Dr. Schipper

    Monheim, 86653

  • Praxis Hermann Ingerl

    Mosbach, 74821

  • Praxis Dr. Jan Feimer

    München, 80539

  • Thoraxzentrum Bez. Unterfranken

    Münnerstadt, 97702

  • Praxis Dipl. med Thomas Hagen

    Neumarkt, 92318

  • Praxis Wanda Wuttke

    Nuremberg, 90478

  • Praxis Dr. Volker E. Trapp

    Nuremberg, 90489

  • Praxis Dipl.-med. Anne-Kathrin Schmidt

    Oschatz, 04758

  • Dr. Bauer

    Potsdam, 14480

  • Praxis Dr. Rudolf Hennig

    Radebeul, 01445

  • Dr. Jasch-Hoppe

    Rathenow, 14712

  • Zentrum für Onkologie

    Rostock, 18107

  • Dres. Herold/Kaa

    Roth , Mittelfr, 91154

  • Lungenfachzentrum Rhein-Main

    Rüsselsheim am Main, 65428

  • MVZ für Atemwegserkrankungen

    Schleswig, 24837

  • Praxis S. Theuer

    Seelow, 15306

  • Dres. Knöbel/Olesch/Pelz-Knöbel

    Straubing, 94315

  • Dr. Eisenschmidt

    Strausberg, 15344

  • Dr. Schröter

    Trier, 54290

  • Dres. Barczok & Kollegen

    Ulm, Donau, 89073

  • Dres. Günther/Günther

    Viernheim, 68519

  • Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann

    Warendorf, 48231

  • Dres. Herold/Kaa

    Weißenburg I Bay, 91781

  • Dres. Geissler/Geissler

    Weißenfels, Saale, 06667

  • Dres. Seidel/Röcher

    Wiefelstede, 26215

  • Dres. Fried/Thomas

    Wiesbaden, 65183

  • Praxis K.P. Schaps/H. Zimmeck

    Wilhelmshaven, 26388

  • Dr. Franz

    Witten, 58452

  • Dr. Weber

    Witten, 58452

  • Praxis D. Kubitscheck

    Wittenberg, 06886

  • Dr. Riegel

    Wolfsburg, 38448

Other trials in Germany

About this study

Official title: AERIAL®: Changes in Health and Functional Status in Patients With COPD During Therapy With Spiolto® Respimat®

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

Read the detailed description

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.

Being tested
Spiolto® Respimat®
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.

  • Spiolto® Respimat®Drug

    Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

    6 weeks

Study groups in NCT03165045
Study groupRoleWhat they receive
patients treated with Spiolto® Respimat®Patients with COPD
Receives: Drug: Spiolto® Respimat®

What is being measured

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

  1. Therapeutic Success

    The primary endpoint of the study was "therapeutic success" at visit 2.

    The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.

    Measured: Final visit at the end of the study, approximately 6 weeks after start of study

Secondary outcomes (4)

  1. Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2

    Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study.

    The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.

    Measured: Final visit at the end of the study, approximately 6 weeks after start of study

  2. General Condition of the Patient

    General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2.

    The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment.

    Measured: Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1

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

    A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.

    The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status.

    Measured: 6 weeks

  4. Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2

    To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment.

    Measured: 6 weeks

Timeline

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

  1. First posted24 May 2017
  2. Study start26 May 2017
  3. Primary completion4 Feb 2019
  4. Study completion24 Mar 2019

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
Cohort
Time perspective
Prospective
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03165045
Sponsor's protocol ID
1237-0065
Status last verified
Apr 2020
First submitted
11 May 2017
Last updated
9 Apr 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gillissen A, Marseille A, Skowasch D, Ritz J, Mattiucci-Guehlke M, Pabst S, Greulich T, Koczulla R. Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL(R) non-interventional study. ERJ Open Res. 2021 Sep 6;7(3):00004-2021. doi: 10.1183/23120541.00004-2021. eCollection 2021 Jul.

    PubMed 34513983

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 108 sites in Germany.

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 5 inclusion and 5 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Germany. 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 1 Apr 2020). 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?

Therapeutic Success (time frame: Final visit at the end of the study, approximately 6 weeks after start of study). 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 NCT03165045, which also lists 1 linked publication.

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 9 Apr 2020.

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