Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)
- Registration Number
- NCT03165045
- Lead Sponsor
- Boehringer Ingelheim
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1351
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients treated with Spiolto® Respimat® Spiolto® Respimat® Patients with COPD
- Primary Outcome Measures
Name Time Method Therapeutic Success 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.
- Secondary Outcome Measures
Name Time Method Patient Satisfaction With Spiolto® Respimat® at Visit 2 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.Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 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.
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 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.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 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.
Trial Locations
- Locations (106)
Dr. Urban
🇩🇪Berlin, Germany
Dr. Kassik
🇩🇪Bitterfeld-Wolfen, Germany
Praxis B. Metzlaff
🇩🇪Büchen, Germany
MZM Medizin Zentr. Marienstrasse
🇩🇪Aldenhoven B Jülich, Germany
Dr. Ludwig
🇩🇪Bad Bentheim, Germany
Praxis Dr. med. Graubner
🇩🇪Bad Sachsa, Germany
Dr. Callitsis
🇩🇪Bad Vilbel, Germany
Praxis Abdullah Sahan
🇩🇪Berlin, Germany
Praxis Dr. Andreas Schwittay
🇩🇪Böhlen, Germany
Dr. Weghmann
🇩🇪Aachen, Germany
Praxis Edgar Hossbach
🇩🇪Berkatal-Frankershausen, Germany
Praxis Edgar Schaubert
🇩🇪Aldenhoven, Germany
Dr. Jung
🇩🇪Bad Ditzenbach, Germany
Dr. Thalhofer
🇩🇪Berlin, Germany
Praxis Dr. Selbig
🇩🇪Ansbach, Germany
Dr. Biedermann
🇩🇪Blankenhain , Thür, Germany
Dr. Franz
🇩🇪Witten, Germany
Dr. Kopf
🇩🇪Berlin, Germany
Dr. Xanthopoulos
🇩🇪Fürstenwalde /Spree, Germany
Dr. Schwiese
🇩🇪Duisburg, Germany
Dr. Kontny
🇩🇪Duisburg, Germany
Dr. Schmidt
🇩🇪Erfurt, Germany
Praxis Dr. Schmorell
🇩🇪Forchheim, Germany
Dres. Engelhard/Wihl
🇩🇪Frankenberg, Germany
Dr. Sommer
🇩🇪Garmisch-Partenkirchen, Germany
Dr. Waida
🇩🇪Haan, Germany
Dr. Morgner
🇩🇪Freiberg, Germany
Praxis J. Lemke
🇩🇪Halle (Saale), Germany
Praxis A. Heinze
🇩🇪Fürstenwalde /Spree, Germany
Dr. Polke
🇩🇪Hamburg, Germany
Dr. Seiz
🇩🇪Leonberg , Württ, Germany
Dres. Berger/Schäfer/Winkels
🇩🇪Düren, Germany
Ges. f. Med. Fortbildung
🇩🇪Düsseldorf, Germany
Dres. Lehmann/Schwerdtfeger
🇩🇪Köthen (Anhalt), Germany
Praxis C. Staack/Z. Zadrozny
🇩🇪Gelsenkirchen, Germany
Dres. Koenen & Partner
🇩🇪Grafenrheinfeld, Germany
Praxis Dr. Bernhard Beckmann
🇩🇪Kamen, Germany
Dr. Saur
🇩🇪Mannheim, Germany
Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer
🇩🇪Friedrichsthal, Germany
Das HausarztZentrum
🇩🇪Grafenrheinfeld, Germany
Dr. Schmitz
🇩🇪Kall, Germany
Praxis Dres. Berg & Partner
🇩🇪Höchstadt, Germany
Praxis D. Kubitscheck
🇩🇪Lutherstadt Wittenberg, Germany
Praxis G. Mohanty
🇩🇪Kamp-Lintfort, Germany
Praxis Dipl. med Thomas Hagen
🇩🇪Neumarkt, Germany
Dres. Kock & Partner
🇩🇪Mainaschaff, Germany
Zentrum für Onkologie
🇩🇪Rostock, Germany
Praxis Wanda Wuttke
🇩🇪Nürnberg, Germany
Praxis Dr. Jan Feimer
🇩🇪München, Germany
MVZ für Atemwegserkrankungen
🇩🇪Schleswig, Germany
Praxis Dr. Rudolf Hennig
🇩🇪Radebeul, Germany
Lungenfachzentrum Rhein-Main
🇩🇪Rüsselsheim, Germany
Praxis S. Theuer
🇩🇪Seelow, Germany
Dr. Bauer
🇩🇪Potsdam, Germany
Dr. Jasch-Hoppe
🇩🇪Rathenow, Germany
Dres. Geissler/Geissler
🇩🇪Weißenfels, Saale, Germany
Dres. Tietjens/Tobias
🇩🇪Dortmund, Germany
Praxis Dr. Kaase
🇩🇪Hamburg, Germany
Praxis Dr. Körössy
🇩🇪Geretsried, Germany
Praxis J. Hinrichs-Pavlik
🇩🇪Heidelberg , Neckar, Germany
Praxis Dr. med. Werner Gams
🇩🇪Gütersloh, Germany
Pneumologicum Halle
🇩🇪Halle (Saale), Germany
Praxis Dr. Constance Koch
🇩🇪Heilbad Heiligenstadt, Germany
Praxis J. Korsakas
🇩🇪Heudeber, Germany
Dr. Schulze
🇩🇪Jerichow, Germany
Praxis Dr. Dietrich Auge
🇩🇪Koblenz, Germany
Praxis Dr. Astrid Pfitzer
🇩🇪Kronach, Germany
KMG Klinikum Mitte GmbH
🇩🇪Kyritz , Prignitz, Germany
Praxis Dr. Hermann A. Trauth
🇩🇪Marburg, Germany
Gemeinschaftspraxis Dres. Jansen/Nolzen
🇩🇪Menden, Germany
Dr. Bartsch
🇩🇪Moers, Germany
Dr. Schipper
🇩🇪Monheim, Germany
Praxis Dr. Volker E. Trapp
🇩🇪Nürnberg, Germany
Dr. Schröter
🇩🇪Trier, Germany
Dr. Riegel
🇩🇪Wolfsburg, Germany
Dr. Junggeburth
🇩🇪Bad Wörishofen, Germany
Gemeinschaftspraxis Dres. Wetterau/Dimar
🇩🇪Biberach, Germany
Praxis Dr. Käßner
🇩🇪Cottbus, Germany
Dres. Ottlewski/Sutor
🇩🇪Burgwedel, Germany
Dres. Forster/Kneser/Steinmetz
🇩🇪Darmstadt, Germany
Gemeinschaftspraxis Dres. Bartels
🇩🇪Breuberg, Germany
Ambulantes Zentrum
🇩🇪Calau, Germany
Dres. Jung/Jung
🇩🇪Deggingen, Germany
Praxis A. Hermann/L. Hermann
🇩🇪Cloppenburg, Germany
Praxis Dr. Andreas Kroll
🇩🇪Einbeck, Germany
Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise
🇩🇪Düsseldorf, Germany
Dres. Brüning/Schax
🇩🇪Essen, Germany
Studienzentrum Dr. Klaus Keller
🇩🇪Frankfurt, Germany
Dr. Abenhardt
🇩🇪Heidelberg, Germany
Praxis Dr. Weberling
🇩🇪Lahnau, Germany
POIS Leipzig GbR
🇩🇪Leipzig, Germany
Dres. Bonitz/Hoheisel
🇩🇪Leipzig, Germany
Praxis Dr. Hannelore Pitule
🇩🇪Ludwigshafen am Rhein, Germany
Praxis Hermann Ingerl
🇩🇪Mosbach, Germany
Thoraxzentrum Bez. Unterfranken
🇩🇪Münnerstadt, Germany
Praxis Dipl.-med. Anne-Kathrin Schmidt
🇩🇪Oschatz, Germany
Dres. Herold/Kaa
🇩🇪Weißenburg I Bay, Germany
Dres. Knöbel/Olesch/Pelz-Knöbel
🇩🇪Straubing, Germany
Dres. Barczok & Kollegen
🇩🇪Ulm, Donau, Germany
Dr. Eisenschmidt
🇩🇪Strausberg, Germany
Dres. Günther/Günther
🇩🇪Viernheim, Germany
Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann
🇩🇪Warendorf, Germany
Dres. Seidel/Röcher
🇩🇪Wiefelstede, Germany
Dres. Fried/Thomas
🇩🇪Wiesbaden, Germany
Praxis K.P. Schaps/H. Zimmeck
🇩🇪Wilhelmshaven, Germany
Dr. Weber
🇩🇪Witten, Germany