Clinical trial NCT03165045: Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)
Official title: AERIAL®: Changes in Health and Functional Status in Patients With COPD During Therapy With Spiolto® Respimat®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 1351
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Success
timeFrame: Final visit at the end of the study, approximately 6 weeks after start of study
Secondary outcomes:
measure: Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
timeFrame: Final visit at the end of the study, approximately 6 weeks after start of study
measure: General Condition of the Patient
timeFrame: 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
measure: Patient Satisfaction With Spiolto® Respimat® at Visit 2
timeFrame: 6 weeks
measure: Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Dr. Weghmann
city: Aldenhoven B Jülich
country: Germany
facility: MZM Medizin Zentr. Marienstrasse
city: Aldenhoven
country: Germany
facility: Praxis Edgar Schaubert
city: Ansbach
country: Germany
facility: Praxis Dr. Selbig
city: Bad Bentheim
country: Germany
facility: Dr. Ludwig
city: Bad Ditzenbach
country: Germany
facility: Dr. Jung
city: Bad Sachsa
country: Germany
facility: Praxis Dr. med. Graubner
city: Bad Vilbel
country: Germany
facility: Dr. Callitsis
city: Bad Wörishofen
country: Germany
facility: Dr. Junggeburth
city: Berkatal-Frankershausen
country: Germany
facility: Praxis Edgar Hossbach
city: Berlin
country: Germany
facility: Dr. Urban
city: Berlin
country: Germany
facility: Praxis Abdullah Sahan
city: Berlin
country: Germany
facility: Dr. Kopf
city: Berlin
country: Germany
facility: Dr. Thalhofer
city: Biberach
country: Germany
facility: Gemeinschaftspraxis Dres. Wetterau/Dimar
city: Bitterfeld-Wolfen
country: Germany
facility: Dr. Kassik
city: Blankenhain , Thür
country: Germany
facility: Dr. Biedermann
city: Breuberg
country: Germany
facility: Gemeinschaftspraxis Dres. Bartels
city: Burgwedel
country: Germany
facility: Dres. Ottlewski/Sutor
city: Böhlen
country: Germany
facility: Praxis Dr. Andreas Schwittay
city: Büchen
country: Germany
facility: Praxis B. Metzlaff
city: Calau
country: Germany
facility: Ambulantes Zentrum
city: Cloppenburg
country: Germany
facility: Praxis A. Hermann/L. Hermann
city: Cottbus
country: Germany
facility: Praxis Dr. Käßner
city: Darmstadt
country: Germany
facility: Dres. Forster/Kneser/Steinmetz
city: Deggingen
country: Germany
facility: Dres. Jung/Jung
city: Dietzenbach
country: Germany
facility: Dr. Franz
city: Dortmund
country: Germany
facility: Dres. Tietjens/Tobias
city: Duisburg
country: Germany
facility: Dr. Schwiese
city: Duisburg
country: Germany
facility: Dr. Kontny
city: Düren
country: Germany
facility: Dres. Berger/Schäfer/Winkels
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise
city: Düsseldorf
country: Germany
facility: Ges. f. Med. Fortbildung
city: Einbeck
country: Germany
facility: Praxis Dr. Andreas Kroll
city: Erfurt
country: Germany
facility: Dr. Schmidt
city: Essen
country: Germany
facility: Dres. Brüning/Schax
city: Forchheim
country: Germany
facility: Praxis Dr. Schmorell
city: Frankenberg
country: Germany
facility: Dres. Engelhard/Wihl
city: Frankfurt
country: Germany
facility: Studienzentrum Dr. Klaus Keller
city: Freiberg
country: Germany
facility: Dr. Morgner
city: Friedrichsthal
country: Germany
facility: Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer
city: Fürstenwalde /Spree
country: Germany
facility: Dr. Xanthopoulos
city: Fürstenwalde /Spree
country: Germany
facility: Praxis A. Heinze
city: Garmisch-Partenkirchen
country: Germany
facility: Dr. Sommer
city: Gelsenkirchen
country: Germany
facility: Praxis C. Staack/Z. Zadrozny
city: Geretsried
country: Germany
facility: Praxis Dr. Körössy
city: Grafenrheinfeld
country: Germany
facility: Das HausarztZentrum
city: Grafenrheinfeld
country: Germany
facility: Dres. Koenen & Partner
city: Gütersloh
country: Germany
facility: Praxis Dr. med. Werner Gams
city: Haan
country: Germany
facility: Dr. Waida
city: Halle (Saale)
country: Germany
facility: Pneumologicum Halle
city: Halle (Saale)
country: Germany
facility: Praxis J. Lemke
city: Hamburg
country: Germany
facility: Dr. Polke
city: Hamburg
country: Germany
facility: Praxis Dr. Kaase
city: Heidelberg , Neckar
country: Germany
facility: Praxis J. Hinrichs-Pavlik
city: Heidelberg
country: Germany
facility: Dr. Abenhardt
city: Heilbad Heiligenstadt
country: Germany
facility: Praxis Dr. Constance Koch
city: Heudeber
country: Germany
facility: Praxis J. Korsakas
city: Höchstadt
country: Germany
facility: Praxis Dres. Berg & Partner
city: Jerichow
country: Germany
facility: Dr. Schulze
city: Kall
country: Germany
facility: Dr. Schmitz
city: Kamen
country: Germany
facility: Praxis Dr. Bernhard Beckmann
city: Kamp-Lintfort
country: Germany
facility: Praxis G. Mohanty
city: Koblenz
country: Germany
facility: Praxis Dr. Dietrich Auge
city: Kronach
country: Germany
facility: Praxis Dr. Astrid Pfitzer
city: Kyritz , Prignitz
country: Germany
facility: KMG Klinikum Mitte GmbH
city: Köthen (Anhalt)
country: Germany
facility: Dres. Lehmann/Schwerdtfeger
city: Lahnau
country: Germany
facility: Praxis Dr. Weberling
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Leipzig
country: Germany
facility: Dres. Bonitz/Hoheisel
city: Leonberg , Württ
country: Germany
facility: Dr. Seiz
city: Ludwigshafen am Rhein
country: Germany
facility: Praxis Dr. Hannelore Pitule
city: Lutherstadt Wittenberg
country: Germany
facility: Praxis D. Kubitscheck
city: Mainaschaff
country: Germany
facility: Dres. Kock & Partner
city: Mannheim
country: Germany
facility: Dr. Saur
city: Marburg
country: Germany
facility: Praxis Dr. Hermann A. Trauth
city: Menden
country: Germany
facility: Gemeinschaftspraxis Dres. Jansen/Nolzen
city: Moers
country: Germany
facility: Dr. Bartsch
city: Monheim
country: Germany
facility: Dr. Schipper
city: Mosbach
country: Germany
facility: Praxis Hermann Ingerl
city: München
country: Germany
facility: Praxis Dr. Jan Feimer
city: Münnerstadt
country: Germany
facility: Thoraxzentrum Bez. Unterfranken
city: Neumarkt
country: Germany
facility: Praxis Dipl. med Thomas Hagen
city: Nürnberg
country: Germany
facility: Praxis Wanda Wuttke
city: Nürnberg
country: Germany
facility: Praxis Dr. Volker E. Trapp
city: Oschatz
country: Germany
facility: Praxis Dipl.-med. Anne-Kathrin Schmidt
city: Potsdam
country: Germany
facility: Dr. Bauer
city: Radebeul
country: Germany
facility: Praxis Dr. Rudolf Hennig
city: Rathenow
country: Germany
facility: Dr. Jasch-Hoppe
city: Rostock
country: Germany
facility: Zentrum für Onkologie
city: Roth , Mittelfr
country: Germany
facility: Dres. Herold/Kaa
city: Rüsselsheim
country: Germany
facility: Lungenfachzentrum Rhein-Main
city: Schleswig
country: Germany
facility: MVZ für Atemwegserkrankungen
city: Seelow
country: Germany
facility: Praxis S. Theuer
city: Straubing
country: Germany
facility: Dres. Knöbel/Olesch/Pelz-Knöbel
city: Strausberg
country: Germany
facility: Dr. Eisenschmidt
city: Trier
country: Germany
facility: Dr. Schröter
city: Ulm, Donau
country: Germany
facility: Dres. Barczok & Kollegen
city: Viernheim
country: Germany
facility: Dres. Günther/Günther
city: Warendorf
country: Germany
facility: Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann
city: Weißenburg I Bay
country: Germany
facility: Dres. Herold/Kaa
city: Weißenfels, Saale
country: Germany
facility: Dres. Geissler/Geissler
city: Wiefelstede
country: Germany
facility: Dres. Seidel/Röcher
city: Wiesbaden
country: Germany
facility: Dres. Fried/Thomas
city: Wilhelmshaven
country: Germany
facility: Praxis K.P. Schaps/H. Zimmeck
city: Witten
country: Germany
facility: Dr. Franz
city: Witten
country: Germany
facility: Dr. Weber
city: Wolfsburg
country: Germany
facility: Dr. Riegel
Study officials:
affiliation: andrea.marseille@boehringer-ingelheim.com
name: Andrea Marseille, 49613277141881
role: STUDY_CHAIR
References:
citation: 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.