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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

AERIAL®: Changes in Health and Functional Status in Patients With COPD During Therapy With Spiolto® Respimat®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165045
• Other study ID #: 1237-0065
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: March 24, 2019

Study information

• Verified date: April 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1351
• Est. completion date: March 24, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Spiolto® Respimat®
6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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