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

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: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Spiolto® Respimat®

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: Observational
• Enrollment (Actual): 1351

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Final visit at the end of the study, approximately 6 weeks after start of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Final visit at the end of the study, approximately 6 weeks after start of study
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.	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	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	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

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Andrea Marseille, 49613277141881, andrea.marseille@boehringer-ingelheim.com

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2017
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): March 24, 2019

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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