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®
1 other identifier
observational
1,351
1 country
108
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
May 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2019
CompletedResults Posted
Study results publicly available
April 1, 2020
CompletedApril 9, 2020
April 1, 2020
1.7 years
May 11, 2017
March 18, 2020
April 1, 2020
Conditions
Outcome Measures
Primary Outcomes (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.
Final visit at the end of the study, approximately 6 weeks after start of study
Secondary Outcomes (4)
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Final visit at the end of the study, approximately 6 weeks after start of study
General Condition of the Patient
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
6 weeks
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
6 weeks
Study Arms (1)
patients treated with Spiolto® Respimat®
Patients with COPD
Interventions
6 weeks
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
Dr. Weghmann
Aachen, 52066, Germany
Praxis Edgar Schaubert
Aldenhoven, 52457, Germany
MZM Medizin Zentr. Marienstrasse
Aldenhoven B Jülich, 52457, Germany
Praxis Dr. Selbig
Ansbach, 91522, Germany
Dr. Ludwig
Bad Bentheim, 48455, Germany
Dr. Jung
Bad Ditzenbach, 73342, Germany
Praxis Dr. med. Graubner
Bad Sachsa, 37441, Germany
Dr. Callitsis
Bad Vilbel, 61118, Germany
Dr. Junggeburth
Bad Wörishofen, 86825, Germany
Praxis Edgar Hossbach
Berkatal-Frankershausen, 37297, Germany
Dr. Urban
Berlin, 10711, Germany
Praxis Abdullah Sahan
Berlin, 12049, Germany
Dr. Kopf
Berlin, 12459, Germany
Dr. Thalhofer
Berlin, 14163, Germany
Gemeinschaftspraxis Dres. Wetterau/Dimar
Biberach, 88400, Germany
Dr. Kassik
Bitterfeld-Wolfen, 06749, Germany
Dr. Biedermann
Blankenhain , Thür, 99444, Germany
Praxis Dr. Andreas Schwittay
Böhlen, 04564, Germany
Gemeinschaftspraxis Dres. Bartels
Breuberg, 64747, Germany
Dres. Ottlewski/Sutor
Burgwedel, 30938, Germany
Praxis B. Metzlaff
Büchen, 21514, Germany
Praxis A. Hermann/L. Hermann
Cloppenburg, 49661, Germany
Praxis Dr. Käßner
Cottbus, 03050, Germany
Dres. Forster/Kneser/Steinmetz
Darmstadt, 64283, Germany
Dres. Jung/Jung
Deggingen, 73326, Germany
Dr. Franz
Dietzenbach, 63128, Germany
Dres. Tietjens/Tobias
Dortmund, 44135, Germany
Dr. Schwiese
Duisburg, 47051, Germany
Dr. Kontny
Duisburg, 47055, Germany
Dres. Berger/Schäfer/Winkels
Düren, 52349, Germany
Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise
Düsseldorf, 40217, Germany
Ges. f. Med. Fortbildung
Düsseldorf, 40547, Germany
Praxis Dr. Andreas Kroll
Einbeck, 37574, Germany
Dr. Schmidt
Erfurt, 99084, Germany
Dres. Brüning/Schax
Essen, 45134, Germany
Praxis Dr. Schmorell
Forchheim, 91301, Germany
Dres. Engelhard/Wihl
Frankenberg, 35066, Germany
Studienzentrum Dr. Klaus Keller
Frankfurt, 60389, Germany
Dr. Morgner
Freiberg, 09599, Germany
Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer
Friedrichsthal, 66299, Germany
Dr. Xanthopoulos
Fürstenwalde, 15517, Germany
Praxis A. Heinze
Fürstenwalde, 15517, Germany
Dr. Sommer
Garmisch-Partenkirchen, 82467, Germany
Praxis C. Staack/Z. Zadrozny
Gelsenkirchen, 45891, Germany
Praxis Dr. Körössy
Geretsried, 82538, Germany
Das HausarztZentrum
Grafenrheinfeld, 97506, Germany
Dres. Koenen & Partner
Grafenrheinfeld, 97506, Germany
Praxis Dr. med. Werner Gams
Gütersloh, 33330, Germany
Dr. Waida
Haan, 42781, Germany
Pneumologicum Halle
Halle, 06108, Germany
Praxis J. Lemke
Halle, 06110, Germany
Dr. Polke
Hamburg, 20357, Germany
Praxis Dr. Kaase
Hamburg, 22529, Germany
Dr. Abenhardt
Heidelberg, 69115, Germany
Praxis J. Hinrichs-Pavlik
Heidelberg , Neckar, 69115, Germany
Praxis Dr. Constance Koch
Heilbad Heiligenstadt, 37308, Germany
Praxis J. Korsakas
Heudeber, 38855, Germany
Praxis Dres. Berg & Partner
Höchstadt an der Aisch, 91315, Germany
Dr. Schulze
Jerichow, 39319, Germany
Ambulantes Zentrum
Kalawa, 03205, Germany
Dr. Schmitz
Kall, 53925, Germany
Praxis Dr. Bernhard Beckmann
Kamen, 59174, Germany
Praxis G. Mohanty
Kamp-Lintfort, 47475, Germany
Praxis Dr. Dietrich Auge
Koblenz, 56068, Germany
Dres. Lehmann/Schwerdtfeger
Köthen, 06366, Germany
Praxis Dr. Astrid Pfitzer
Kronach, 96317, Germany
KMG Klinikum Mitte GmbH
Kyritz , Prignitz, 16866, Germany
Praxis Dr. Weberling
Lahnau, 35633, Germany
POIS Leipzig GbR
Leipzig, 04357, Germany
Dres. Bonitz/Hoheisel
Leipzig, 4275, Germany
Dr. Seiz
Leonberg , Württ, 71229, Germany
Praxis Dr. Hannelore Pitule
Ludwigshafen am Rhein, 67061, Germany
Dres. Kock & Partner
Mainaschaff, 63814, Germany
Dr. Saur
Mannheim, 68161, Germany
Praxis Dr. Hermann A. Trauth
Marburg, 35037, Germany
Gemeinschaftspraxis Dres. Jansen/Nolzen
Menden, 58706, Germany
Dr. Bartsch
Moers, 47441, Germany
Dr. Schipper
Monheim, 86653, Germany
Praxis Hermann Ingerl
Mosbach, 74821, Germany
Praxis Dr. Jan Feimer
München, 80539, Germany
Thoraxzentrum Bez. Unterfranken
Münnerstadt, 97702, Germany
Praxis Dipl. med Thomas Hagen
Neumarkt, 92318, Germany
Praxis Wanda Wuttke
Nuremberg, 90478, Germany
Praxis Dr. Volker E. Trapp
Nuremberg, 90489, Germany
Praxis Dipl.-med. Anne-Kathrin Schmidt
Oschatz, 04758, Germany
Dr. Bauer
Potsdam, 14480, Germany
Praxis Dr. Rudolf Hennig
Radebeul, 01445, Germany
Dr. Jasch-Hoppe
Rathenow, 14712, Germany
Zentrum für Onkologie
Rostock, 18107, Germany
Dres. Herold/Kaa
Roth , Mittelfr, 91154, Germany
Lungenfachzentrum Rhein-Main
Rüsselsheim am Main, 65428, Germany
MVZ für Atemwegserkrankungen
Schleswig, 24837, Germany
Praxis S. Theuer
Seelow, 15306, Germany
Dres. Knöbel/Olesch/Pelz-Knöbel
Straubing, 94315, Germany
Dr. Eisenschmidt
Strausberg, 15344, Germany
Dr. Schröter
Trier, 54290, Germany
Dres. Barczok & Kollegen
Ulm, Donau, 89073, Germany
Dres. Günther/Günther
Viernheim, 68519, Germany
Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann
Warendorf, 48231, Germany
Dres. Herold/Kaa
Weißenburg I Bay, 91781, Germany
Dres. Geissler/Geissler
Weißenfels, Saale, 06667, Germany
Dres. Seidel/Röcher
Wiefelstede, 26215, Germany
Dres. Fried/Thomas
Wiesbaden, 65183, Germany
Praxis K.P. Schaps/H. Zimmeck
Wilhelmshaven, 26388, Germany
Dr. Franz
Witten, 58452, Germany
Dr. Weber
Witten, 58452, Germany
Praxis D. Kubitscheck
Wittenberg, 06886, Germany
Dr. Riegel
Wolfsburg, 38448, Germany
Related Publications (1)
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.
PMID: 34513983DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Andrea Marseille, 49613277141881
andrea.marseille@boehringer-ingelheim.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 24, 2017
Study Start
May 26, 2017
Primary Completion
February 4, 2019
Study Completion
March 24, 2019
Last Updated
April 9, 2020
Results First Posted
April 1, 2020
Record last verified: 2020-04