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

April 1, 2020 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52066
        • Dr. Weghmann
      • Aldenhoven, Germany, 52457
        • Praxis Edgar Schaubert
      • Aldenhoven B Jülich, Germany, 52457
        • MZM Medizin Zentr. Marienstrasse
      • Ansbach, Germany, 91522
        • Praxis Dr. Selbig
      • Bad Bentheim, Germany, 48455
        • Dr. Ludwig
      • Bad Ditzenbach, Germany, 73342
        • Dr. Jung
      • Bad Sachsa, Germany, 37441
        • Praxis Dr. med. Graubner
      • Bad Vilbel, Germany, 61118
        • Dr. Callitsis
      • Bad Wörishofen, Germany, 86825
        • Dr. Junggeburth
      • Berkatal-Frankershausen, Germany, 37297
        • Praxis Edgar Hossbach
      • Berlin, Germany, 10711
        • Dr. Urban
      • Berlin, Germany, 12049
        • Praxis Abdullah Sahan
      • Berlin, Germany, 12459
        • Dr. Kopf
      • Berlin, Germany, 14163
        • Dr. Thalhofer
      • Biberach, Germany, 88400
        • Gemeinschaftspraxis Dres. Wetterau/Dimar
      • Bitterfeld-Wolfen, Germany, 06749
        • Dr. Kassik
      • Blankenhain , Thür, Germany, 99444
        • Dr. Biedermann
      • Breuberg, Germany, 64747
        • Gemeinschaftspraxis Dres. Bartels
      • Burgwedel, Germany, 30938
        • Dres. Ottlewski/Sutor
      • Böhlen, Germany, 04564
        • Praxis Dr. Andreas Schwittay
      • Büchen, Germany, 21514
        • Praxis B. Metzlaff
      • Calau, Germany, 03205
        • Ambulantes Zentrum
      • Cloppenburg, Germany, 49661
        • Praxis A. Hermann/L. Hermann
      • Cottbus, Germany, 03050
        • Praxis Dr. Käßner
      • Darmstadt, Germany, 64283
        • Dres. Forster/Kneser/Steinmetz
      • Deggingen, Germany, 73326
        • Dres. Jung/Jung
      • Dietzenbach, Germany, 63128
        • Dr. Franz
      • Dortmund, Germany, 44135
        • Dres. Tietjens/Tobias
      • Duisburg, Germany, 47051
        • Dr. Schwiese
      • Duisburg, Germany, 47055
        • Dr. Kontny
      • Düren, Germany, 52349
        • Dres. Berger/Schäfer/Winkels
      • Düsseldorf, Germany, 40217
        • Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise
      • Düsseldorf, Germany, 40547
        • Ges. f. Med. Fortbildung
      • Einbeck, Germany, 37574
        • Praxis Dr. Andreas Kroll
      • Erfurt, Germany, 99084
        • Dr. Schmidt
      • Essen, Germany, 45134
        • Dres. Brüning/Schax
      • Forchheim, Germany, 91301
        • Praxis Dr. Schmorell
      • Frankenberg, Germany, 35066
        • Dres. Engelhard/Wihl
      • Frankfurt, Germany, 60389
        • Studienzentrum Dr. Klaus Keller
      • Freiberg, Germany, 09599
        • Dr. Morgner
      • Friedrichsthal, Germany, 66299
        • Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer
      • Fürstenwalde /Spree, Germany, 15517
        • Dr. Xanthopoulos
      • Fürstenwalde /Spree, Germany, 15517
        • Praxis A. Heinze
      • Garmisch-Partenkirchen, Germany, 82467
        • Dr. Sommer
      • Gelsenkirchen, Germany, 45891
        • Praxis C. Staack/Z. Zadrozny
      • Geretsried, Germany, 82538
        • Praxis Dr. Körössy
      • Grafenrheinfeld, Germany, 97506
        • Das HausarztZentrum
      • Grafenrheinfeld, Germany, 97506
        • Dres. Koenen & Partner
      • Gütersloh, Germany, 33330
        • Praxis Dr. med. Werner Gams
      • Haan, Germany, 42781
        • Dr. Waida
      • Halle (Saale), Germany, 06108
        • Pneumologicum Halle
      • Halle (Saale), Germany, 06110
        • Praxis J. Lemke
      • Hamburg, Germany, 20357
        • Dr. Polke
      • Hamburg, Germany, 22529
        • Praxis Dr. Kaase
      • Heidelberg, Germany, 69115
        • Dr. Abenhardt
      • Heidelberg , Neckar, Germany, 69115
        • Praxis J. Hinrichs-Pavlik
      • Heilbad Heiligenstadt, Germany, 37308
        • Praxis Dr. Constance Koch
      • Heudeber, Germany, 38855
        • Praxis J. Korsakas
      • Höchstadt, Germany, 91315
        • Praxis Dres. Berg & Partner
      • Jerichow, Germany, 39319
        • Dr. Schulze
      • Kall, Germany, 53925
        • Dr. Schmitz
      • Kamen, Germany, 59174
        • Praxis Dr. Bernhard Beckmann
      • Kamp-Lintfort, Germany, 47475
        • Praxis G. Mohanty
      • Koblenz, Germany, 56068
        • Praxis Dr. Dietrich Auge
      • Kronach, Germany, 96317
        • Praxis Dr. Astrid Pfitzer
      • Kyritz , Prignitz, Germany, 16866
        • KMG Klinikum Mitte GmbH
      • Köthen (Anhalt), Germany, 06366
        • Dres. Lehmann/Schwerdtfeger
      • Lahnau, Germany, 35633
        • Praxis Dr. Weberling
      • Leipzig, Germany, 04357
        • POIS Leipzig GbR
      • Leipzig, Germany, 4275
        • Dres. Bonitz/Hoheisel
      • Leonberg , Württ, Germany, 71229
        • Dr. Seiz
      • Ludwigshafen am Rhein, Germany, 67061
        • Praxis Dr. Hannelore Pitule
      • Lutherstadt Wittenberg, Germany, 06886
        • Praxis D. Kubitscheck
      • Mainaschaff, Germany, 63814
        • Dres. Kock & Partner
      • Mannheim, Germany, 68161
        • Dr. Saur
      • Marburg, Germany, 35037
        • Praxis Dr. Hermann A. Trauth
      • Menden, Germany, 58706
        • Gemeinschaftspraxis Dres. Jansen/Nolzen
      • Moers, Germany, 47441
        • Dr. Bartsch
      • Monheim, Germany, 86653
        • Dr. Schipper
      • Mosbach, Germany, 74821
        • Praxis Hermann Ingerl
      • München, Germany, 80539
        • Praxis Dr. Jan Feimer
      • Münnerstadt, Germany, 97702
        • Thoraxzentrum Bez. Unterfranken
      • Neumarkt, Germany, 92318
        • Praxis Dipl. med Thomas Hagen
      • Nürnberg, Germany, 90478
        • Praxis Wanda Wuttke
      • Nürnberg, Germany, 90489
        • Praxis Dr. Volker E. Trapp
      • Oschatz, Germany, 04758
        • Praxis Dipl.-med. Anne-Kathrin Schmidt
      • Potsdam, Germany, 14480
        • Dr. Bauer
      • Radebeul, Germany, 01445
        • Praxis Dr. Rudolf Hennig
      • Rathenow, Germany, 14712
        • Dr. Jasch-Hoppe
      • Rostock, Germany, 18107
        • Zentrum für Onkologie
      • Roth , Mittelfr, Germany, 91154
        • Dres. Herold/Kaa
      • Rüsselsheim, Germany, 65428
        • Lungenfachzentrum Rhein-Main
      • Schleswig, Germany, 24837
        • MVZ für Atemwegserkrankungen
      • Seelow, Germany, 15306
        • Praxis S. Theuer
      • Straubing, Germany, 94315
        • Dres. Knöbel/Olesch/Pelz-Knöbel
      • Strausberg, Germany, 15344
        • Dr. Eisenschmidt
      • Trier, Germany, 54290
        • Dr. Schröter
      • Ulm, Donau, Germany, 89073
        • Dres. Barczok & Kollegen
      • Viernheim, Germany, 68519
        • Dres. Günther/Günther
      • Warendorf, Germany, 48231
        • Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann
      • Weißenburg I Bay, Germany, 91781
        • Dres. Herold/Kaa
      • Weißenfels, Saale, Germany, 06667
        • Dres. Geissler/Geissler
      • Wiefelstede, Germany, 26215
        • Dres. Seidel/Röcher
      • Wiesbaden, Germany, 65183
        • Dres. Fried/Thomas
      • Wilhelmshaven, Germany, 26388
        • Praxis K.P. Schaps/H. Zimmeck
      • Witten, Germany, 58452
        • Dr. Franz
      • Witten, Germany, 58452
        • Dr. Weber
      • Wolfsburg, Germany, 38448
        • Dr. Riegel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients treated with Spiolto® Respimat®
Patients with COPD
Drug: Spiolto® Respimat®
6 weeks
Other Names:
  • INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapeutic Success
Time Frame: Final visit at the end of the study, approximately 6 weeks after start of study

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Time Frame: Final visit at the end of the study, approximately 6 weeks after start of study

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.
Final visit at the end of the study, approximately 6 weeks after start of study
General Condition of the Patient
Time Frame: 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

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.
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
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Time Frame: 6 weeks

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.
6 weeks
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Andrea Marseille, 49613277141881, andrea.marseille@boehringer-ingelheim.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1237-0065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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